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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03038620
Other study ID # STU 122015-044
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 2017
Est. completion date October 13, 2020

Study information

Verified date October 2021
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a clinical study to investigate the efficacy of liraglutide compared to placebo in reducing visceral adiposity measured by MRI in overweight or obese subjects at high risk for cardiovascular disease after 40 weeks on-treatment.


Description:

Obesity has long been recognized as a risk factor for all-cause mortality and morbidity, including the development of cardiovascular and metabolic diseases such as coronary artery disease, hypertension, insulin resistance, diabetes, and dyslipidemia. Obesity has recently been formally defined as a chronic disease characterized by pathophysiological processes that result in increased adipose tissue mass and can result in increased morbidity and mortality. Although the health risks associated with obesity are clear, there is an emerging appreciation that obesity per se, as defined by simple anthropometric measures such as waist circumference or body mass index (BMI), is neither necessary nor sufficient to promote cardiometabolic disease and atherosclerotic cardiovascular disease (ASCVD) risk. As a result, BMI alone is an insufficient marker of risk and may not accurately identify individuals at elevated risk for ASCVD. There is a pressing need to more accurately phenotype obesity to identify individuals at elevated risk for ASCVD that may benefit from more intensive preventive and therapeutic strategies


Recruitment information / eligibility

Status Completed
Enrollment 235
Est. completion date October 13, 2020
Est. primary completion date October 13, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years and older
Eligibility Inclusion Criteria: - Age = 35 years - Able to provide informed consent - BMI = 30 kg/m2 or = 27 kg/m2 with metabolic syndrome - Metabolic syndrome is defined as at least three of the following:3 1. waist circumference > 102 cm (40 in) in men and 88 cm (35 in) in women 2. triglycerides > 150 mg/dL or on treatment for hypertriglyceridemia 3. HDL cholesterol < 40 mg/dL in men and < 50 mg/dL in women 4. blood pressure > 130/85 mmHg or on treatment for hypertension 5. fasting glucose > 100 mg/dL Exclusion Criteria: - Treatment with Glucagon-like peptide-1 (GLP-1) receptor agonists (including liraglutide, exenatide or others as they become available), dipeptidyl peptidase 4 (DPP-4) inhibitors or insulin within the last 3 months. - Receipt of any anti-obesity drug or supplement within 1 month prior to screening for this trial. - Self-reported or clinically documented history of significant fluctuations (>5% change) in weight within 3 months prior to screening for this trial. - History of diabetes mellitus (type 1 or 2) or on treatment with anti-diabetes medication. - History of chronic pancreatitis or idiopathic acute pancreatitis (current or prior history). - History of gallbladder disease (cholelithiasis or cholecystitis). - Chronic kidney disease stage III or greater (eGFR<60 mL/min). - Obesity induced by other endocrinologic disorders (e.g. Cushing Syndrome). - Current or history of treatment with medications that may cause significant weight gain, within 1 month prior to screening for this trial, including systemic corticosteroids (except for a short course of treatment, i.e., 7- 10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g., imipramine, amitryptiline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium). - Diet attempts using herbal supplements or over-the-counter medications within 1 month prior to screening for this trial. - Current participation in an organized weight reduction program or within the last 1 month prior to screening for this trial. - Participation in a clinical trial within the last 3 months prior to screening for this trial. - Familial or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma. - Personal history of non-familial medullary thyroid carcinoma. - History of Major Depressive Disorder within the last 2 years. - History of other severe psychiatric disorders, e.g., schizophrenia, bipolar disorder. - Any lifetime history of a suicide attempt. - A history of any suicidal behavior in the last month prior to randomization. - Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the Investigator. - Known or suspected hypersensitivity to trial product(s) or related product(s). - Known or suspected abuse of alcohol or narcotics. - Language barrier, mental incapacity, unwillingness or inability to understand. - Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods. These include abstinence and the following methods: diaphragm with spermicide, condom with spermicide (by male partner), intrauterine device, sponge, spermicide, Norplant®, Depo-Provera® or oral contraceptives.

Study Design


Intervention

Drug:
Liraglutide
Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Placebo
Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.

Locations

Country Name City State
United States University of Texas Southwestern Medical Center Dallas Texas

Sponsors (2)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (25)

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Astrup A, Carraro R, Finer N, Harper A, Kunesova M, Lean ME, Niskanen L, Rasmussen MF, Rissanen A, Rössner S, Savolainen MJ, Van Gaal L; NN8022-1807 Investigators. Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide. Int J Obes (Lond). 2012 Jun;36(6):843-54. doi: 10.1038/ijo.2011.158. Epub 2011 Aug 16. Erratum in: Int J Obes (Lond). 2012 Jun;36(6):890. Int J Obes (Lond). 2013 Feb;37(2):322. — View Citation

Astrup A, Rössner S, Van Gaal L, Rissanen A, Niskanen L, Al Hakim M, Madsen J, Rasmussen MF, Lean ME; NN8022-1807 Study Group. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. Lancet. 2009 Nov 7;374(9701):1606-16. doi: 10.1016/S0140-6736(09)61375-1. Epub 2009 Oct 23. Erratum in: Lancet. 2010 Mar 20;375(9719):984. — View Citation

Berrington de Gonzalez A, Hartge P, Cerhan JR, Flint AJ, Hannan L, MacInnis RJ, Moore SC, Tobias GS, Anton-Culver H, Freeman LB, Beeson WL, Clipp SL, English DR, Folsom AR, Freedman DM, Giles G, Hakansson N, Henderson KD, Hoffman-Bolton J, Hoppin JA, Koenig KL, Lee IM, Linet MS, Park Y, Pocobelli G, Schatzkin A, Sesso HD, Weiderpass E, Willcox BJ, Wolk A, Zeleniuch-Jacquotte A, Willett WC, Thun MJ. Body-mass index and mortality among 1.46 million white adults. N Engl J Med. 2010 Dec 2;363(23):2211-9. doi: 10.1056/NEJMoa1000367. Erratum in: N Engl J Med. 2011 Sep 1;365(9):869. — View Citation

Borga M, Thomas EL, Romu T, Rosander J, Fitzpatrick J, Dahlqvist Leinhard O, Bell JD. Validation of a fast method for quantification of intra-abdominal and subcutaneous adipose tissue for large-scale human studies. NMR Biomed. 2015 Dec;28(12):1747-53. doi: 10.1002/nbm.3432. Epub 2015 Nov 2. — View Citation

Britton KA, Massaro JM, Murabito JM, Kreger BE, Hoffmann U, Fox CS. Body fat distribution, incident cardiovascular disease, cancer, and all-cause mortality. J Am Coll Cardiol. 2013 Sep 3;62(10):921-5. doi: 10.1016/j.jacc.2013.06.027. Epub 2013 Jul 10. — View Citation

Cerhan JR, Moore SC, Jacobs EJ, Kitahara CM, Rosenberg PS, Adami HO, Ebbert JO, English DR, Gapstur SM, Giles GG, Horn-Ross PL, Park Y, Patel AV, Robien K, Weiderpass E, Willett WC, Wolk A, Zeleniuch-Jacquotte A, Hartge P, Bernstein L, Berrington de Gonzalez A. A pooled analysis of waist circumference and mortality in 650,000 adults. Mayo Clin Proc. 2014 Mar;89(3):335-45. doi: 10.1016/j.mayocp.2013.11.011. — View Citation

Chandra A, Neeland IJ, Berry JD, Ayers CR, Rohatgi A, Das SR, Khera A, McGuire DK, de Lemos JA, Turer AT. The relationship of body mass and fat distribution with incident hypertension: observations from the Dallas Heart Study. J Am Coll Cardiol. 2014 Sep 9;64(10):997-1002. doi: 10.1016/j.jacc.2014.05.057. — View Citation

Després JP, Lemieux I, Bergeron J, Pibarot P, Mathieu P, Larose E, Rodés-Cabau J, Bertrand OF, Poirier P. Abdominal obesity and the metabolic syndrome: contribution to global cardiometabolic risk. Arterioscler Thromb Vasc Biol. 2008 Jun;28(6):1039-49. doi: 10.1161/ATVBAHA.107.159228. Epub 2008 Mar 20. Review. Erratum in: Arterioscler Thromb Vasc Biol. 2008 Jul;28(7):e151. — View Citation

Després JP. Body fat distribution and risk of cardiovascular disease: an update. Circulation. 2012 Sep 4;126(10):1301-13. doi: 10.1161/CIRCULATIONAHA.111.067264. Review. — View Citation

Dong Z, Luo Y, Zhang Z, Cai H, Li Y, Chan T, Wu L, Li ZP, Feng ST. MR quantification of total liver fat in patients with impaired glucose tolerance and healthy subjects. PLoS One. 2014 Oct 24;9(10):e111283. doi: 10.1371/journal.pone.0111283. eCollection 2014. — View Citation

Garvey WT, Garber AJ, Mechanick JI, Bray GA, Dagogo-Jack S, Einhorn D, Grunberger G, Handelsman Y, Hennekens CH, Hurley DL, McGill J, Palumbo P, Umpierrez G; The Aace Obesity Scientific Committee. American association of clinical endocrinologists and american college of endocrinology position statement on the 2014 advanced framework for a new diagnosis of obesity as a chronic disease. Endocr Pract. 2014 Sep;20(9):977-89. doi: 10.4158/EP14280.PS. — View Citation

Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Fernando Costa. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute scientific statement: Executive Summary. Crit Pathw Cardiol. 2005 Dec;4(4):198-203. — View Citation

Hsu WC, Araneta MR, Kanaya AM, Chiang JL, Fujimoto W. BMI cut points to identify at-risk Asian Americans for type 2 diabetes screening. Diabetes Care. 2015 Jan;38(1):150-8. doi: 10.2337/dc14-2391. Review. — View Citation

Human energy requirements: report of a joint FAO/ WHO/UNU Expert Consultation. Food Nutr Bull. 2005 Mar;26(1):166. — View Citation

McLaughlin T, Lamendola C, Liu A, Abbasi F. Preferential fat deposition in subcutaneous versus visceral depots is associated with insulin sensitivity. J Clin Endocrinol Metab. 2011 Nov;96(11):E1756-60. doi: 10.1210/jc.2011-0615. Epub 2011 Aug 24. — View Citation

McLaughlin T, Sherman A, Tsao P, Gonzalez O, Yee G, Lamendola C, Reaven GM, Cushman SW. Enhanced proportion of small adipose cells in insulin-resistant vs insulin-sensitive obese individuals implicates impaired adipogenesis. Diabetologia. 2007 Aug;50(8):1707-15. Epub 2007 Jun 5. — View Citation

Mørkedal B, Vatten LJ, Romundstad PR, Laugsand LE, Janszky I. Risk of myocardial infarction and heart failure among metabolically healthy but obese individuals: HUNT (Nord-Trøndelag Health Study), Norway. J Am Coll Cardiol. 2014 Mar 25;63(11):1071-8. doi: 10.1016/j.jacc.2013.11.035. Epub 2013 Dec 15. — View Citation

Neeland IJ, Ayers CR, Rohatgi AK, Turer AT, Berry JD, Das SR, Vega GL, Khera A, McGuire DK, Grundy SM, de Lemos JA. Associations of visceral and abdominal subcutaneous adipose tissue with markers of cardiac and metabolic risk in obese adults. Obesity (Silver Spring). 2013 Sep;21(9):E439-47. doi: 10.1002/oby.20135. Epub 2013 May 19. — View Citation

Neeland IJ, Gupta S, Ayers CR, Turer AT, Rame JE, Das SR, Berry JD, Khera A, McGuire DK, Vega GL, Grundy SM, de Lemos JA, Drazner MH. Relation of regional fat distribution to left ventricular structure and function. Circ Cardiovasc Imaging. 2013 Sep;6(5):800-7. doi: 10.1161/CIRCIMAGING.113.000532. Epub 2013 Aug 8. — View Citation

Neeland IJ, Turer AT, Ayers CR, Powell-Wiley TM, Vega GL, Farzaneh-Far R, Grundy SM, Khera A, McGuire DK, de Lemos JA. Dysfunctional adiposity and the risk of prediabetes and type 2 diabetes in obese adults. JAMA. 2012 Sep 19;308(11):1150-9. — View Citation

Schaudinn A, Linder N, Garnov N, Kerlikowsky F, Blüher M, Dietrich A, Schütz T, Karlas T, Kahn T, Busse H. Predictive accuracy of single- and multi-slice MRI for the estimation of total visceral adipose tissue in overweight to severely obese patients. NMR Biomed. 2015 May;28(5):583-90. doi: 10.1002/nbm.3286. Epub 2015 Mar 25. — View Citation

See R, Abdullah SM, McGuire DK, Khera A, Patel MJ, Lindsey JB, Grundy SM, de Lemos JA. The association of differing measures of overweight and obesity with prevalent atherosclerosis: the Dallas Heart Study. J Am Coll Cardiol. 2007 Aug 21;50(8):752-9. Epub 2007 Aug 6. — View Citation

Thomas MS, Newman D, Leinhard OD, Kasmai B, Greenwood R, Malcolm PN, Karlsson A, Rosander J, Borga M, Toms AP. Test-retest reliability of automated whole body and compartmental muscle volume measurements on a wide bore 3T MR system. Eur Radiol. 2014 Sep;24(9):2279-91. doi: 10.1007/s00330-014-3226-6. Epub 2014 May 29. — View Citation

Wadden TA, Hollander P, Klein S, Niswender K, Woo V, Hale PM, Aronne L; NN8022-1923 Investigators. Weight maintenance and additional weight loss with liraglutide after low-calorie-diet-induced weight loss: the SCALE Maintenance randomized study. Int J Obes (Lond). 2013 Nov;37(11):1443-51. doi: 10.1038/ijo.2013.120. Epub 2013 Jul 1. Erratum in: Int J Obes (Lond). 2013 Nov;37(11):1514. Int J Obes (Lond). 2015 Jan;39(1):187. — View Citation

* Note: There are 25 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other On-treatment Time, Weeks The mean duration of treatment during study follow-up. weeks
Primary Relative Percent Reduction in Visceral Adipose Tissue Mass Measured by MRI The effect on relative percent reduction from baseline in visceral adipose tissue mass measured by MRI after 40 weeks on treatment.
Positive numbers reflect the reduction in the value from baseline to study endpoint as a percent of the baseline.
Reduction in this variable is believed to be associated with lower cardiovascular risk.
Baseline, 40 weeks
Secondary Absolute Reduction in Visceral Adipose Tissue Volume The effect on absolute reduction from baseline in visceral adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
Reduction in this variable is believed to be associated with lower cardiovascular risk.
Baseline, 40 weeks
Secondary Relative Percent Reduction in Body Weight The effect on relative percent reduction from baseline in body weight after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
Reduction in this variable is believed to be associated with lower cardiovascular risk.
Baseline, 40 weeks
Secondary Absolute Reduction in Body Weight The effect on absolute reduction from baseline in body weight after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
Reduction in this variable is believed to be associated with lower cardiovascular risk.
Baseline, 40 weeks
Secondary Relative Percent Reduction in Waist Circumference The effect on relative percent reduction from baseline in waist circumference after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
Reduction in this variable is believed to be associated with lower cardiovascular risk.
Baseline, 40 weeks
Secondary Absolute Reduction in Waist Circumference The effect on absolute reduction from baseline in waist circumference after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
Reduction in this variable is believed to be associated with lower cardiovascular risk.
Baseline, 40 weeks
Secondary Relative Percent Reduction in Total Body Adipose Tissue The effect on relative percent reduction from baseline in total body adipose tissue (fat) mass measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
Reduction in this variable is believed to be associated with lower cardiovascular risk.
Baseline, 40 weeks
Secondary Absolute Reduction in Total Body Adipose Tissue The effect on absolute reduction from baseline in total body adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
Reduction in this variable is believed to be associated with lower cardiovascular risk.
Baseline, 40 weeks
Secondary Relative Percent Reduction in Abdominal Subcutaneous Adipose Tissue The effect on relative percent reduction from baseline in abdominal subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
Baseline, 40 weeks
Secondary Absolute Reduction in Abdominal Subcutaneous Adipose Tissue The effect on absolute reduction from baseline in abdominal subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
Baseline, 40 weeks
Secondary Relative Percent Reduction in Lower Body Subcutaneous Adipose Tissue The effect on relative percent reduction from baseline in lower body subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
Baseline, 40 weeks
Secondary Absolute Reduction in Lower Body Subcutaneous Adipose Tissue The effect on absolute reduction from baseline in lower body subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
Baseline, 40 weeks
Secondary Relative Percent Reduction in Liver Fat Percent The effect on relative percent reduction from baseline in liver (hepatic) fat percentage measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.
Reduction in this variable is believed to be associated with lower cardiovascular risk.
Baseline, 40 weeks
Secondary Absolute Reduction in Liver Fat Percent The effect on absolute reduction from baseline in liver (hepatic) fat percentage measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.
Reduction in this variable is believed to be associated with lower cardiovascular risk.
Baseline, 40 weeks
Secondary Relative Percent Reduction in Total Body Lean Volume The effect on relative percent reduction from baseline in total body lean volume (fat-free mass) measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
Baseline, 40 weeks
Secondary Absolute Reduction in Total Body Lean Volume The effect on absolute reduction from baseline in total body lean volume (fat-free mass) measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
Baseline, 40 weeks
Secondary Relative Percent Reduction in Total Thigh Muscle Volume The effect on relative percent reduction from baseline in total thigh muscle volume measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
Baseline, 40 weeks
Secondary Absolute Reduction in Total Thigh Muscle Volume The effect on absolute reduction from baseline in total thigh muscle volume measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
Baseline, 40 weeks
Secondary Relative Percent Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent The effect on relative percent reduction from baseline in mean anterior thigh muscle fat infiltration percent measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.
Reduction in this variable is believed to be associated with lower risk for metabolic disease.
Baseline,40 weeks
Secondary Absolute Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent The effect on absolute reduction from baseline in mean anterior thigh muscle fat infiltration percent measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.
Reduction in this variable is believed to be associated with lower risk for metabolic disease
Baseline,40 weeks
Secondary Change From Baseline in VAT/SAT Ratio The effect on absolute reduction from baseline in Visceral adipose tissue/subcutaneous adipose tissue (VAT/SAT) ratio measured by MRI after 40 weeks on treatment versus placebo.
Positive numbers reflect the reduction in the value from baseline to study endpoint.
This is the ratio of visceral adipose tissue to subcutaneous adipose tissue and it is thought that lower values (relatively less visceral adipose tissue) are better.
Baseline, 40 weeks
Secondary Change From Baseline in Total Fat/Fat-free Mass Ratio The effect on absolute change from baseline in total fat/fat-free mass ratio measured by MRI after 40 weeks on treatment versus placebo.
This is a ratio of fat to lean mass and it is believed that lower values (less fat relative to lean mass) is better.
Baseline, 40 weeks
Secondary Relative Percent Change in Fasting Blood Glucose The relative percent change in fasting blood glucose from baseline to study end point as a percent of baseline by treatment group.
Negative values reflect a reduction. This is a blood based biomarker for diabetes in which normal levels are desirable (70-100 mg/dL).
Baseline, 40 weeks
Secondary Relative Percent Change in Insulin The relative percent change in insulin from baseline to study end point as a percent of baseline by treatment group.
Positive values reflect an increase. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.
This is a blood based biomarker in which lower fasting levels are desirable.
Baseline, 40 weeks
Secondary Relative Percent Change in HOMA-IR The relative percent change in HOMA-IR from baseline to study end point as a percent of baseline by treatment group.
Positive values reflect an increase. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.
The relative percent change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to study end point by treatment group measures insulin resistance. Levels above 1.9 signal early insulin resistance, while levels above 2.9 signal significant insulin resistance. There will be optimal insulin sensitivity if HOMA-IR is less than 1.
Baseline, 40 weeks
Secondary Relative Percent Change in C-reactive Protein The relative percent change in biomarker of inflammation: C-reactive protein (CRP) from baseline to study end point as a percent of baseline by treatment group.
Negative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.
This is a blood based test for which lower values are associated with less inflammation and lower risk for cardiovascular events.
Baseline, 40 weeks
Secondary Relative Percent Change in Triglyceride/HDL-C Ratio The relative percent change in triglyceride/HDL-C ratio from baseline to study end point as a percent of baseline by treatment group.
Negative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.
Lower ratio of triglycerides to HDL-cholesterol is associated with less insulin resistance and lower cardiovascular risk.
Baseline, 40 weeks
Secondary Relative Percent Change in Nt-proBNP The relative percent change in N-terminal Pro Brain Natriuretic Peptides (Nt-proBNP) from baseline to study end point as a percent of baseline by treatment group.
Negative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.
NT-proBNP is a blood based biomarker. Lower levels are associated with lower risk for heart failure and cardiovascular events.
Baseline, 40 weeks
Secondary Absolute Change in Fasting Blood Glucose The change in fasting blood glucose from baseline to study end point by treatment group. Baseline,40 weeks
Secondary Absolute Change in Insulin The absolute change in insulin from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits. Baseline, 40 weeks
Secondary Absolute Change in HOMA-IR The absolute change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to study end point by treatment group measures insulin resistance. Levels above 1.9 signal early insulin resistance, while levels above 2.9 signal significant insulin resistance. There will be optimal insulin sensitivity if HOMA-IR is less than 1. Collection was impacted by COVID-19 and changes to study visits. Baseline, 40 weeks
Secondary Absolute Change in CRP The change in Markers of inflammation: C-reactive protein (CRP) from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.
This is a blood based test for which lower values are associated with less inflammation and lower risk for cardiovascular events.
Baseline, 40 weeks
Secondary Absolute Change in Triglyceride/HDL-C Ratio The change in triglyceride/HDL-C ratio from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.
Lower ratio of triglycerides to HDL-cholesterol is associated with less insulin resistance and lower cardiovascular risk.
Baseline, 40 weeks
Secondary Absolute Change in Nt-proBNP The change in N-terminal Pro Brain Natriuretic Peptides (Nt-proBNP) from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.
NT-proBNP is a blood based biomarker. Lower levels are associated with lower risk for heart failure and cardiovascular events.
Baseline, 40 weeks
Secondary Change From Baseline in Heart Rate The change in heart rate/pulse from baseline to study endpoint visit by treatment group. Baseline, 40 weeks
Secondary Change From Baseline in Blood Pressure The change in systolic blood pressure from baseline to study endpoint visit by treatment group. Baseline, 40 weeks
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