Practice Based Nutrition Intervention-2

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2

In brief

This study aims to test hypotheses that are potentially important to diabetes management, with practical implications for reducing the medical, personal, and economic costs of the disease. Anticipated outcomes include reductions in glycosylated hemoglobin that are significantly greater than those achievable with current diet recommendations, reductions in medication use among many intervention-group participants, beneficial changes in body weight and serum lipid concentrations, and a demonstration of the acceptability of the intervention diet. Progress toward these goals could refine dietary guidance for individuals with diabetes, increase treatment expectations, and reduce the massive burden the disease currently imposes. The study further attempts to translate a dietary intervention studied in a clinical research setting to a medical practice. This will contribute to developing a model for diabetes care that can be used widely.

Key facts

Study ID

NCT01700868

Run by

Physicians Committee for Responsible Medicine

People needed

15

Starts

2014-07-01

Expected to finish

2015-07-01

Last updated by the study team

2015-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 care
• diabetes medications unchanged for 1 month prior to volunteering for the study
• patient of Dr. Mark Sklar

You may not qualify if…

• 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
• 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

Where it is running

• Physicians Committee for Responsible Medicine — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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