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

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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.


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
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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