Clinical trial NCT01931631: Plant-Based Dietary Intervention in Type 2 Diabetes-2
Official title: A Practice-Based, Nutrition Intervention in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Diet, Vegetarian
Diet, Fat-Restricted
Glycemic Index
Lead sponsor: Physicians Committee for Responsible Medicine
Sponsor class: OTHER
Collaborators: name: George Washington University
First posted: 2013-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess whether, in individuals with type 2 diabetes, a low-fat, vegan diet improves blood glucose control more effectively than a control diet based on current American Diabetes Association (ADA) guidelines. The principal measure is hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The study duration is 20 weeks with a one-year follow-up.

Detailed description: Preliminary evidence suggests that low-fat, vegetarian regimens similar to those used to reverse coronary artery blockages may have a significant beneficial effect on type 2 diabetes, as demonstrated by reductions in fasting serum glucose concentrations and medication use. The investigators therefore randomly assigned 99 individuals with type 2 diabetes to either a low-fat, vegan diet or a diet based on current American Diabetes Association guidelines for 22 weeks with a one-year follow-up period. The principal dependent measure is hemoglobin A1c. Cardiovascular risk factors are also being tracked, as is dietary acceptance.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Type 2 Diabetes Mellitus

Exclusion Criteria:

- hemoglobin A1c values \<6.5% or \>10.5% use of insulin for \> 5 years tobacco use within the preceding 6 months consumption of more than 2 alcoholic beverages per day current drug abuse pregnancy unstable medical status current use of a low-fat, vegetarian diet.

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 20 weeks
Secondary outcomes:
measure: Body Weight
timeFrame: 20 Weeks
measure: Blood Pressure
timeFrame: 20 Weeks
measure: Glucose
timeFrame: 20 Weeks
measure: Comprehensive Metabolic Panel
timeFrame: 20 Weeks & one-year follow up
measure: Serum cholesterol and triacylglycerol concentrations
timeFrame: 20 Weeks
measure: Urinary albumin and creatinine
timeFrame: 20 Weeks
measure: Genotyping for Taq1 A and Taq1 B polymorphisms, and APOE (Apolipoprotein E)
timeFrame: 20 Weeks
measure: Waist and hip circumference
timeFrame: 20 Weeks
measure: Dietary Acceptability
timeFrame: 20 Weeks
measure: 3-day dietary records
timeFrame: 20 Weeks
measure: International Physical Activity Questionnaire
timeFrame: 20 Weeks
measure: Food Acceptability Questionnaire
timeFrame: 20 Weeks
measure: Eating Inventory
timeFrame: 20 Weeks
measure: CESD-R (Center for Epidemiologic Studies Depression Scale: Review and revision)
timeFrame: 20 Weeks
measure: Beck Depression Inventory II (BDI-II)
timeFrame: 20 Weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Physicians Committee for Responsible Medicine
state: District of Columbia
Study officials:
affiliation: George Washington University
name: Joshua Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ornish D, Scherwitz LW, Billings JH, Brown SE, Gould KL, Merritt TA, Sparler S, Armstrong WT, Ports TA, Kirkeeide RL, Hogeboom C, Brand RJ. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998 Dec 16;280(23):2001-7. doi: 10.1001/jama.280.23.2001.
citation: Esselstyn CB Jr. Updating a 12-year experience with arrest and reversal therapy for coronary heart disease (an overdue requiem for palliative cardiology). Am J Cardiol. 1999 Aug 1;84(3):339-41, A8. doi: 10.1016/s0002-9149(99)00290-8.
citation: Nicholson AS, Sklar M, Barnard ND, Gore S, Sullivan R, Browning S. Toward improved management of NIDDM: A randomized, controlled, pilot intervention using a lowfat, vegetarian diet. Prev Med. 1999 Aug;29(2):87-91. doi: 10.1006/pmed.1999.0529.