A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics

Completed · Phase 2

Conditions studied: Diabetes Type II

In brief

The study is a small pilot, designed to provide data regarding the feasibility and acceptability of conducting such a study on a larger scale. The present study is a randomized controlled clinical trial comparing two mindfulness-based lifestyle modification programs to help people manage diabetes and lose weight, one using on a low-carbohydrate diet (LC) and the other using a moderate-carbohydrate diet promoted by the American Diabetes Association (ADA). Intervention content will include information about nutrition (carbohydrate restriction or American Diabetes Association recommended diet) and emotion regulation and mindful eating strategies.

Key facts

Study ID

NCT01713764

Run by

University of California, San Francisco

People needed

34

Starts

2012-10-01

Expected to finish

2013-11-01

Last updated by the study team

2013-12-30

Who can join

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

You may qualify if…

• Diabetes mellitus, Type 2.
• HgbA1c > 6.0% at screening. This is to confirm the diabetes diagnosis.
• Aged 18 years old and older
• BMI 25 and above.

You may not qualify if…

• Condition that will make it difficult for participation. Such as:
• cancer
• liver failure
• unstable coronary artery disease
• severe emphysema
• bulimia or strong history of bulimia
• vegan
• Laboratory evidence of organ dysfunction
• Abnormal kidney function (serum creatinine)
• thyroid stimulating hormone out of normal range
• Previous use or new changes in medications that can interfere with the measures used in the study:
• current use of insulin and no immediate plans to start or increase diabetic mediations.
• more than 3 oral hypoglycemic medications.
• use of systemic (oral or IV) corticosteroids in the 6 months prior
• severe autoimmune disorders
• initiation of psychiatric medications in past 2 months.
• Weight loss confounds
• Current use of weight loss medications or supplements.
• History of or planned weight loss surgery.
• Other
• Pregnant or planning to get pregnant in the next year, breastfeeding, less than 6 months post-partum.
• Unable or unwilling to do home glucose monitoring.

Where it is running

• Osher Center for Integrative Medicine — San Francisco, California, United States

Full record on ClinicalTrials.gov

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