Status:
COMPLETED
Practice Based Nutrition Intervention
Lead Sponsor:
Physicians Committee for Responsible Medicine
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study aims to test a dietary intervention for diabetes in a medical practice setting, with the aim of developing a model for diabetes care that can be used widely. The investigators hypothesize t...
Detailed Description
Specific Aim 1 tests the hypothesis that the nutrition intervention (low fat, low-GI vegan diet) improves glycemic control, body weight, plasma lipid concentrations, blood pressure, and indices of ren...
Eligibility Criteria
Inclusion
- a diagnosis of type 2 diabetes mellitus, as defined by a fasting plasma glucose concentration ≥126 mg/dl on 2 occasions or a prior physician's diagnosis of type 2 diabetes with the use of hypoglycemic medications for at least 6 months
- male or female
- A1c between 6.5% and 10.5%
- age at least 18 years
- ability and willingness to participate in all components of the study
- willingness to be assigned to either a low-fat, vegan diet or to standard nutrition care
- diabetes medications unchanged for 1 month prior to volunteering for the study
- patient of Dr. Mark Sklar
Exclusion
- body mass index \>45 kg/m2
- alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
- use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
- pregnancy or plans to become pregnant
- history of severe mental illness (with current unstable status)
- likely to be disruptive in group sessions (as determined by research staff)
- Signs/symptoms of acute uncontrolled diabetes (including but not limited to polyuria, polydipsia, blurred vision, uncontrolled weight loss)
- unstable medical status
- already following a low-fat, vegetarian diet
- an inordinate fear of blood draws
- inability to maintain current medication regimen
- lack of English fluency
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01222429
Start Date
October 1 2010
End Date
February 1 2012
Last Update
August 7 2012
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