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Completed

NCT Number: NCT01713764

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

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.

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Key information

Conditions

Diabetes Type II Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Osher Center for Integrative Medicine

San Francisco, California, 94143, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

low carbohydrate diet

Behavioral

American Diabetes Association Diet

Behavioral

Mindfulness and Positive Affect Skills

Behavioral

Primary outcomes

  1. Hemoglobin A1c

    Time frame: Change from baseline to 3 months

    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.

Secondary outcomes

  1. Hemoglobin A1c

    Time frame: Change from baseline to 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: SUCCEED

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 25, 2012
Registry last updated
Dec 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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