Type 2 Diabetes Mellitus in Obese
Conditions
Brief summary
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.
Interventions
OTHERNDPR diet
nutrient rich plant based diert
OTHERUSDA healthy eating diet
DASH diet
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control | change at 1, 3, 6, 9, 12 months | A1C and finger stick blood sugar levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| body weight | change at 1, 3, 6, 9, 12 months | — |
| body composition | change at 1,3,6,9, 12 months | DXA scan |
| hepatic steatosis | baseline, 1, 3, 6, 9, 12 months | MRspectroscopy |
| inflammatory markers | change at, 1, 3, 6, 9, 12 months | serum inflammatory markers |
| quality of life | change at, 1, 3, 6, 9, 12 months | validated questionnaired |
Countries
United States
Outcome results
None listed