Effect of a Plant Rich Diet on in People With Type 2 Diabetes and Obesity

Withdrawn before enrolling · Not applicable

Conditions studied: Type 2 Diabetes Mellitus in Obese

In brief

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.

Key facts

Study ID

NCT02977039

Run by

Beth Israel Deaconess Medical Center

People needed

0

Starts

2019-11-01

Expected to finish

2020-06-01

Last updated by the study team

2020-01-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women ages 18-75
• Type 2 diabetes mellitus diagnosed > 6 months prior to screening visit according to American Diabetes Association criteria
• HBA1c >7.5% but < 10%
• BMI >25 kg/m2 ; >23 kg/m2 for Asian subjects but < 45 kg/m2
• Stable weight (variation < 5 kg within 6 months of screening visit)
• Ability to give informed consent
• Ability to follow verbal and written instructions in English

You may not qualify if…

• 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
• Persistent uncontrolled hypertension (BP > 160/100 mmHg on or off antihypertensive medication)
• Active marijuana or intravenous drug use
• Recent weight loss (> 5 kg within 6 months of the screening visit)
• Inflammatory or irritable bowel disease (Crohn's Disease, Ulcerative Colitis, or IBS)
• Celiac disease
• Malignancy treated with chemotherapy within the past 1 year
• Depression or psychosis requiring hospitalization within 1 year, or use of major antipsychotic or tranquilizer drugs (i.e. benzodiazepines)
• Renal insufficiency (creatinine clearance < 30 ml/min)
• Transaminases > 2x above the normal range
• Pregnancy within 6 months of the screening visit
• Lactation
• History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling
• History of alcohol abuse within the past 5 years
• Vegetarian/Vegan diet
• Dairy Allergy/Intolerance
• Anemia, including iron deficient and megaloblastic
• Vitamin B12 deficiency
• Leber's disease

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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