Dietary Intervention in Type-2 Diabetes and Pre-Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Dietary Intervention in Type-2 Diabetics and Pre-Diabetics Emphasizing Personalized Carbohydrate Intake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519309
• Other study ID #: 2015-1
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: April 2021

Study information

• Verified date: July 2020
• Source: Virta Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this research is to demonstrate the therapeutic effects of implementing a well-formulated low carbohydrate lifestyle program over 2 years in patients with type 2 diabetes, pre-diabetes, and metabolic syndrome.

Description:

The primary purpose of this research is to demonstrate the therapeutic effects of implementing a well-formulated low carbohydrate lifestyle program over 2 years. Positive therapeutic effects would be represented by improved glycemic control in patients with type 2 diabetes without use of additional glycemic control medications and failure to progress to type 2 diabetes in individuals with pre-diabetes and metabolic syndrome.

Secondary purposes of this research are to determine if therapeutic effects of the intervention differ between patients who self-select onsite vs. web-based education delivery, explore relationships between change in LDL cholesterol and carotid intima media thickness, and to evaluate the sustainability of health outcomes achieved and the economic impact of therapeutic effects over 5 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 465
• Est. completion date: April 2021
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

Body weight/Diabetes:

• Diagnosis of type-2 diabetes with BMI > 25 (without end-organ failure)

• Fasting glucose >126 mg/dL or HbA1c >6.5

Body weight/ Pre-diabetes:

• Diagnosis of metabolic syndrome with BMI >30 and HbA1c > 5.6 (note: this does not apply to usual care control subjects)

Ethnicity: all ethnic groups

Exclusion Criteria:

• BMI <30 without diagnosis of Type-2 diabetes, metabolic syndrome

• Type 1 diabetes

• History of keto-acidosis

• History of MI, stroke, angina, coronary insufficiency within the last 6 months

• Diabetic retinopathy requiring treatment

• Creatinine > 2.0

• Urinary albumin > 1 g/d

• Impaired hepatic function (Bilirubin >2, Albumin < 3.5)

• Cholelithiasis or biliary dysfunction

• Cancer requiring treatment in the past 5 years, with the exception of non-melanoma skin cancer

• Chronic infectious disease requiring ongoing treatment

• Other chronic diseases or condition likely to limit lifespan to <6 years

• Non-English speaking

• Unable or unwilling to participate in group sessions (e.g., plans to relocate within the next year) or conform to a carbohydrate restricted diet lifestyle (e.g., food intolerances, religious or personal restrictions)

• Weight loss of >10% in past 6 months

• Currently pregnant or nursing, or planning to become pregnant during the study

• Major psychiatric disorder (e.g., schizophrenia, bipolar disorder) currently uncontrolled

• Excessive alcohol intake (acute or chronic) defined as average consumption of 3 or more alcohol-containing beverages daily or consumption of more than 14 alcoholic beverages per week

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Metabolic Syndrome
• Pre-diabetes
• Prediabetic State

Intervention

Other:
• Virta Program

Locations

Country	Name	City	State
United States	IU Health Arnett Medical Weight Loss	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Virta Health

Country where clinical trial is conducted

United States, 

References & Publications (25)

Action to Control Cardiovascular Risk in Diabetes Study Group, Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Friedewald WT. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2545-59. doi: 10.1056/NEJMoa0802743. Epub 2008 Jun 6. — View Citation

ADVANCE Collaborative Group, Patel A, MacMahon S, Chalmers J, Neal B, Billot L, Woodward M, Marre M, Cooper M, Glasziou P, Grobbee D, Hamet P, Harrap S, Heller S, Liu L, Mancia G, Mogensen CE, Pan C, Poulter N, Rodgers A, Williams B, Bompoint S, de Galan BE, Joshi R, Travert F. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2560-72. doi: 10.1056/NEJMoa0802987. Epub 2008 Jun 6. — View Citation

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Gardner CD. Tailoring dietary approaches for weight loss. Int J Obes Suppl. 2012 Jul;2(Suppl 1):S11-S15. — View Citation

Gumbiner B, Wendel JA, McDermott MP. Effects of diet composition and ketosis on glycemia during very-low-energy-diet therapy in obese patients with non-insulin-dependent diabetes mellitus. Am J Clin Nutr. 1996 Jan;63(1):110-5. — View Citation

Hussain TA, Mathew TC, Dashti AA, Asfar S, Al-Zaid N, Dashti HM. Effect of low-calorie versus low-carbohydrate ketogenic diet in type 2 diabetes. Nutrition. 2012 Oct;28(10):1016-21. doi: 10.1016/j.nut.2012.01.016. Epub 2012 Jun 5. — View Citation

McClain AD, Otten JJ, Hekler EB, Gardner CD. Adherence to a low-fat vs. low-carbohydrate diet differs by insulin resistance status. Diabetes Obes Metab. 2013 Jan;15(1):87-90. doi: 10.1111/j.1463-1326.2012.01668.x. Epub 2012 Aug 22. — View Citation

Mozumdar A, Liguori G. Persistent increase of prevalence of metabolic syndrome among U.S. adults: NHANES III to NHANES 1999-2006. Diabetes Care. 2011 Jan;34(1):216-9. doi: 10.2337/dc10-0879. Epub 2010 Oct 1. — View Citation

Nielsen JV, Joensson EA. Low-carbohydrate diet in type 2 diabetes: stable improvement of bodyweight and glycemic control during 44 months follow-up. Nutr Metab (Lond). 2008 May 22;5:14. doi: 10.1186/1743-7075-5-14. — View Citation

Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity among adults: United States, 2011-2012. NCHS Data Brief. 2013 Oct;(131):1-8. — View Citation

Petersen KF, Dufour S, Savage DB, Bilz S, Solomon G, Yonemitsu S, Cline GW, Befroy D, Zemany L, Kahn BB, Papademetris X, Rothman DL, Shulman GI. The role of skeletal muscle insulin resistance in the pathogenesis of the metabolic syndrome. Proc Natl Acad Sci U S A. 2007 Jul 31;104(31):12587-94. Epub 2007 Jul 18. — View Citation

Qi Q, Bray GA, Smith SR, Hu FB, Sacks FM, Qi L. Insulin receptor substrate 1 gene variation modifies insulin resistance response to weight-loss diets in a 2-year randomized trial: the Preventing Overweight Using Novel Dietary Strategies (POUNDS LOST) trial. Circulation. 2011 Aug 2;124(5):563-71. doi: 10.1161/CIRCULATIONAHA.111.025767. Epub 2011 Jul 11. — View Citation

Robroek SJ, van den Berg TI, Plat JF, Burdorf A. The role of obesity and lifestyle behaviours in a productive workforce. Occup Environ Med. 2011 Feb;68(2):134-9. doi: 10.1136/oem.2010.055962. Epub 2010 Sep 27. — View Citation

Santos FL, Esteves SS, da Costa Pereira A, Yancy WS Jr, Nunes JP. Systematic review and meta-analysis of clinical trials of the effects of low carbohydrate diets on cardiovascular risk factors. Obes Rev. 2012 Nov;13(11):1048-66. doi: 10.1111/j.1467-789X.2012.01021.x. Epub 2012 Aug 21. Review. — View Citation

Seip RL, Volek JS, Windemuth A, Kocherla M, Fernandez ML, Kraemer WJ, Ruaño G. Physiogenomic comparison of human fat loss in response to diets restrictive of carbohydrate or fat. Nutr Metab (Lond). 2008 Feb 6;5:4. doi: 10.1186/1743-7075-5-4. — View Citation

Shimazu T, Hirschey MD, Newman J, He W, Shirakawa K, Le Moan N, Grueter CA, Lim H, Saunders LR, Stevens RD, Newgard CB, Farese RV Jr, de Cabo R, Ulrich S, Akassoglou K, Verdin E. Suppression of oxidative stress by ß-hydroxybutyrate, an endogenous histone deacetylase inhibitor. Science. 2013 Jan 11;339(6116):211-4. doi: 10.1126/science.1227166. Epub 2012 Dec 6. — View Citation

Stein JH, Korcarz CE, Hurst RT, Lonn E, Kendall CB, Mohler ER, Najjar SS, Rembold CM, Post WS; American Society of Echocardiography Carotid Intima-Media Thickness Task Force. Use of carotid ultrasound to identify subclinical vascular disease and evaluate cardiovascular disease risk: a consensus statement from the American Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular Medicine. J Am Soc Echocardiogr. 2008 Feb;21(2):93-111; quiz 189-90. doi: 10.1016/j.echo.2007.11.011. Review. Erratum in: J Am Soc Echocardiogr. 2008 Apr;21(4):376. — View Citation

Volek JS, Feinman RD. Carbohydrate restriction improves the features of Metabolic Syndrome. Metabolic Syndrome may be defined by the response to carbohydrate restriction. Nutr Metab (Lond). 2005 Nov 16;2:31. — View Citation

Volek JS, Fernandez ML, Feinman RD, Phinney SD. Dietary carbohydrate restriction induces a unique metabolic state positively affecting atherogenic dyslipidemia, fatty acid partitioning, and metabolic syndrome. Prog Lipid Res. 2008 Sep;47(5):307-18. doi: 10.1016/j.plipres.2008.02.003. Epub 2008 Mar 15. Review. — View Citation

Volek JS, Phinney SD, Forsythe CE, Quann EE, Wood RJ, Puglisi MJ, Kraemer WJ, Bibus DM, Fernandez ML, Feinman RD. Carbohydrate restriction has a more favorable impact on the metabolic syndrome than a low fat diet. Lipids. 2009 Apr;44(4):297-309. doi: 10.1007/s11745-008-3274-2. Epub 2008 Dec 12. — View Citation

Yancy WS Jr, Foy M, Chalecki AM, Vernon MC, Westman EC. A low-carbohydrate, ketogenic diet to treat type 2 diabetes. Nutr Metab (Lond). 2005 Dec 1;2:34. — View Citation

Zhang X, Qi Q, Zhang C, Smith SR, Hu FB, Sacks FM, Bray GA, Qi L. FTO genotype and 2-year change in body composition and fat distribution in response to weight-loss diets: the POUNDS LOST Trial. Diabetes. 2012 Nov;61(11):3005-11. doi: 10.2337/db11-1799. Epub 2012 Aug 13. Erratum in: Diabetes. 2013 Feb;62(2):662. Smith, Steven R [added]; Bray, George A [added]. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Type-2 Diabetes Status	Type-2 diabetes status will be evaluated by measuring Hemoglobin A1c (HbA1c)	3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Primary	Change from Baseline Metabolic Syndrome Status	Metabolic syndrome status will be evaluated by standard markers. Metabolic syndrome is defined as having at least three of the following: Waist circumference: =40 inches (men) or =35 inches (women); Fasting triglycerides: =150 mg/dL; HDL-C: <40 mg/dL (men) or <50 mg/dL (women); Blood pressure: =130/85 mm Hg or use of hypertensive medication; Fasting glucose: = 100 mg/dL or use of hyperglycemia medication	3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Primary	Change from Baseline Body Weight	Body weight will be evaluated on a calibrated scale	3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Secondary	Change from Baseline Carotid Intima Media Thickness (CIMT) (intervention and usual care arms, participants with type 2 diabetes only)	Ultrasound Measurement of the Carotid Artery	12 and 24 Months
Secondary	Change from Baseline Serum Lipids	Serum lipids including lipoprotein size and number	3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Secondary	Change from Baseline Body Composition	Body composition will be determined using dual-energy X-ray absorptiometry (DXA), which provides accurate information on total body and regional fat, lean body mass, and bone mass	3,12 and 24 Months (intervention arms only)
Secondary	Change from Baseline Type-2 Diabetes Status	Type-2 diabetes status will be evaluated by measuring Hemoglobin A1c (HbA1c)	42 and 60 Months (intervention arms only)
Secondary	Change from Baseline Metabolic Syndrome Status	Metabolic syndrome status will be evaluated by standard markers. Metabolic syndrome is defined as having at least three of the following: Waist circumference: =40 inches (men) or =35 inches (women); Fasting triglycerides: =150 mg/dL; HDL-C: <40 mg/dL (men) or <50 mg/dL (women); Blood pressure: =130/85 mm Hg or use of hypertensive medication; Fasting glucose: = 100 mg/dL or use of hyperglycemia medication	42 and 60 Months (intervention arms only)
Secondary	Change from Baseline Body Weight	Body weight will be evaluated on a calibrated scale	42 and 60 Months (intervention arms only)