Obesity Clinical Trial
Official title:
Effects of a Plant-Based Diet on Insulin Requirements and Obesity Markers in Obese Adults With T2DM
Verified date | March 2022 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a crossover study utilizing a Dietary Approaches to Stop Hypertension (DASH) diet and a whole-food, plant-based diet among subjects with type 2 diabetes who require insulin. Outcomes are short-term changes in insulin requirements and changes in various biomarkers.
Status | Completed |
Enrollment | 15 |
Est. completion date | February 10, 2022 |
Est. primary completion date | February 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults (older than 18 years old) of both genders, of all races and ethnicities. - Pre-existing diagnosis of Type 2 Diabetes Mellitus, as documented in medical records on basal with or without mealtime bolus insulin with no change to total of basal insulin and nutritional baseline insulin dosing > 10% in the 1 month prior to consent and no changes to non-insulin antihyperglycemic medications in the 3 months prior to consent - If on a GLP-1 analog, on a stable dose for at least 3 months prior to the study enrollment - If on an SGLT2 inhibitor, on a stable dose for at least 3 months prior to the study enrollment - BMI of 27 kg/m2 or greater - Most recent HbA1c (within 6 months prior to consent) between 6.5% and 9.5% - Fluent in the English language (education about each diet will be in English) - Willingness and ability to participate in study protocol. - Agreeable to give informed consent. Exclusion Criteria: - Diagnosis of T1DM or type 1.5 diabetes mellitus - History of liver cirrhosis - Impaired renal function (GFR < 45 ml/min) within 6 months prior to consent - History of hyperkalemia (potassium > 5.4 meq/L) within 6 months prior to consent - Use of an insulin pump or expected to start during the study period - Use of warfarin (Coumadin) - Use of daily aspirin 500 mg or more or expected to start during the study period - Use of daily Vitamin C of 1,000 mg or more, unless willing to stop taking 1 week prior to baseline visit and for duration of study - Use of antipsychotics or systemic steroids within 3 months prior to consent - Use of any of the following weight-lowering pharmacotherapy within 3 months prior to consent: phentermine, orlistat, lorcaserin, phentermine/topiramate, bupropion/naloxone - The use of insulin secretagogues including sulfonylureas and glinides within 3 months prior to consent as this may increase the risk of hypoglycemia and alter assessment of daily insulin requirements during the study - The use of illicit drugs, defined as active use or use within 3 months prior to consent. - Engage in high risk alcohol use (defined as more than 4 drinks on any day or more than 14 drinks per week in men and more than 3 drinks on any day or 7 drinks per week in women). - Individuals who are pregnant or breastfeeding or intend to become pregnant during the duration of the study - Individuals who are following a vegetarian or vegan diet at the time of consent - Food allergies or intolerances that will interfere with diet adherence - Lack of access to a full-size refrigerator (required for storage of 3-4 days of prepared study meals) - Active malabsorption disorder, including uncontrolled symptomatic inflammatory bowel disease, or bariatric surgery in the past 1 year |
Country | Name | City | State |
---|---|---|---|
United States | UR Medicine/Highland Hospital Nutrition in Medicine Research Center | Webster | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in total daily insulin requirements | 7 Days | ||
Secondary | Changes in glucose excursion curve | 7 days | ||
Secondary | Changes in serum leptin | 7 days | ||
Secondary | Changes in serum adiponectin | 7 days | ||
Secondary | Changes in serum C-peptide levels | 7 days | ||
Secondary | Changes in serum insulin levels | 7 days | ||
Secondary | Change in lipid panel | 7 days | ||
Secondary | Change in hsCRP | 7 days | ||
Secondary | Change in IL-6 | 7 days | ||
Secondary | Change in IL-18 | 7 days | ||
Secondary | Change in TNF-a | 7 days | ||
Secondary | Change in urinary catecholamines | 7 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |