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

Type 2 Diabetes Mellitus in Obese Clinical Trial

Official title:

Effect of a Nutrient Dense Plant Rich Diet on Glycemic Control in People With Type 2 Diabetes and Obesity

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02977039
• Other study ID #: 2016P000321
• Status: Withdrawn
• Phase: N/A
• Start date: November 2019
• Est. completion date: June 2020

Study information

• Verified date: January 2020
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus in Obese

Intervention

Other:
• NDPR diet
nutrient rich plant based diert
• USDA healthy eating diet
DASH diet

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control	A1C and finger stick blood sugar levels	change at 1, 3, 6, 9, 12 months
Secondary	body weight		change at 1, 3, 6, 9, 12 months
Secondary	body composition	DXA scan	change at 1,3,6,9, 12 months
Secondary	hepatic steatosis	MRspectroscopy	baseline, 1, 3, 6, 9, 12 months
Secondary	inflammatory markers	serum inflammatory markers	change at, 1, 3, 6, 9, 12 months
Secondary	quality of life	validated questionnaired	change at, 1, 3, 6, 9, 12 months