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

Diabetes Type II Clinical Trial

— SUCCEED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01713764
• Other study ID #: 12-09549
• Status: Completed
• Phase: Phase 2
• First received: August 24, 2012
• Last updated: December 24, 2013
• Start date: October 2012
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Approximately 40 individuals with Type II diabetes or prediabetes will be randomized in a 1:1 ratio to treatment groups. Groups will meet for 12 weekly sessions, then approximately biweekly for 3 sessions, for a total of 15 1.5-2 hour sessions over 4.5 months. Participants will be evaluated at 0, 1 month, 3 months, and 6 months. Our outcome of interest is HbA1c (glycated hemoglobin, a measure indicative of blood glucose levels and tied to diabetes severity).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type II

Intervention

Behavioral:
• Low Carbohydrate Diet

• American Diabetes Association Diet

• Mindfulness and Positive Affect Skills

Locations

Country	Name	City	State
United States	Osher Center for Integrative Medicine	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	We test whether Hemoglobin A1c changes from pre-intervention to 3 months. The key outcome measure will compare the two diet groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 3 months.	Change from baseline to 3 months	No
Secondary	Hemoglobin A1c	We test whether Hemoglobin A1c changes from pre-intervention to 6 months. The key outcome measure will compare the two diet groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 6 months.	Change from baseline to 6 months	No