Effect of a Plant Rich Diet on in People With Type 2 Diabetes and Obesity
Status: | Not yet recruiting |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 10/13/2018 |
Start Date: | January 2019 |
End Date: | June 2020 |
Contact: | Jody Dushay, MD |
Email: | jdushay@bidmc.harvard.edu |
Phone: | 617 667 1996 |
Effect of a Nutrient Dense Plant Rich Diet on Glycemic Control in People With Type 2 Diabetes and Obesity
The purpose of this study is to evaluate the effect of a nutrient dense plant rich (NDPR)
diet compared to a standard USDA diet on glycemic control, inflammation, and cardiovascular
risk in individuals with type 2 diabetes and overweight/obesity.
diet compared to a standard USDA diet on glycemic control, inflammation, and cardiovascular
risk in individuals with type 2 diabetes and overweight/obesity.
Inclusion Criteria:
1. Men and women ages 18-75
2. Type 2 diabetes mellitus diagnosed > 6 months prior to screening visit according to
American Diabetes Association criteria
3. HBA1c >7.5% but < 10%
4. BMI >25 kg/m2 ; >23 kg/m2 for Asian subjects but < 45 kg/m2
5. Stable weight (variation < 5 kg within 6 months of screening visit)
6. Ability to give informed consent
7. Ability to follow verbal and written instructions in English
Exclusion Criteria:
1. Active cardiac issues: history of myocardial infarction within 3 months of screening
visit, unstable angina pectoris, or Class III or Class IV congestive heart failure
2. Persistent uncontrolled hypertension (BP > 160/100 mmHg on or off antihypertensive
medication)
3. Active marijuana or intravenous drug use
4. Recent weight loss (> 5 kg within 6 months of the screening visit)
5. Inflammatory or irritable bowel disease (Crohn's Disease, Ulcerative Colitis, or IBS)
6. Celiac disease
7. Malignancy treated with chemotherapy within the past 1 year
8. Depression or psychosis requiring hospitalization within 1 year, or use of major
antipsychotic or tranquilizer drugs (i.e. benzodiazepines)
9. Renal insufficiency (creatinine clearance < 30 ml/min)
10. Transaminases > 2x above the normal range
11. Pregnancy within 6 months of the screening visit
12. Lactation
13. History of surgery for the treatment of obesity (gastric banding, gastric bypass,
gastric stapling
14. History of alcohol abuse within the past 5 years
15. Vegetarian/Vegan diet
16. Dairy Allergy/Intolerance
17. Anemia, including iron deficient and megaloblastic
18. Vitamin B12 deficiency
19. Leber's disease
We found this trial at
1
site
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
Click here to add this to my saved trials