Clinical trial NCT01713764: A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics
Official title: A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Type II
Keywords: diabetes
obesity
mindful eating
positive affect
low carbohydrate
diet
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2012-10-25
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: Change from baseline to 3 months
Secondary outcomes:
measure: Hemoglobin A1c
timeFrame: Change from baseline to 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Osher Center for Integrative Medicine
state: California
Study officials:
affiliation: University of California, San Francisco
name: Frederick M Hecht, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saslow LR, Kim S, Daubenmier JJ, Moskowitz JT, Phinney SD, Goldman V, Murphy EJ, Cox RM, Moran P, Hecht FM. A randomized pilot trial of a moderate carbohydrate diet compared to a very low carbohydrate diet in overweight or obese individuals with type 2 diabetes mellitus or prediabetes. PLoS One. 2014 Apr 9;9(4):e91027. doi: 10.1371/journal.pone.0091027. eCollection 2014.