A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics
NCT ID: NCT01713764
Last Updated: 2013-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
34 participants
INTERVENTIONAL
2012-10-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Low Carbohydrate Diet
Participants will be instructed to follow a low carbohydrate diet: carbohydrate intake 10-50 grams a day not including fiber. Foods permitted include: meats, poultry, fish, eggs, cheese, cream, some nuts and seeds, green leafy vegetables, and most other non-starchy vegetables. Because most individuals self-limit caloric intake, no calorie restriction will be recommended.
Participants will also be taught information about mindfulness and positive affect practices. The mindfulness-based curriculum will focus on the following elements: training on topics such as mindful meditation, mindful eating, awareness of fullness and hunger signals, and taste satiety. The positive emotion curriculum will include: training on topics such as noticing and savoring positive events, gratitude, positive reappraisal, personal strengths, attainable goals, and acts of kindness.
Low Carbohydrate Diet
Mindfulness and Positive Affect Skills
American Diabetes Association Diet
Participants in the American Diabetes Association (ADA) diet group will receive standard ADA advice. The diet includes high-fiber foods (such as vegetables, fruits, whole grains, and legumes), low-fat dairy products, fresh fish, and foods low in saturated fat.
Participants will also be taught information about mindfulness and positive affect practices. The mindfulness-based curriculum will focus on the following elements: training on topics such as mindful meditation, mindful eating, awareness of fullness and hunger signals, and taste satiety. The positive emotion curriculum will include: training on topics such as noticing and savoring positive events, gratitude, positive reappraisal, personal strengths, attainable goals, and acts of kindness.
American Diabetes Association Diet
Mindfulness and Positive Affect Skills
Interventions
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Low Carbohydrate Diet
American Diabetes Association Diet
Mindfulness and Positive Affect Skills
Eligibility Criteria
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Inclusion Criteria
* HgbA1c \> 6.0% at screening. This is to confirm the diabetes diagnosis.
* Aged 18 years old and older
* BMI 25 and above.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Frederick M Hecht, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Osher Center for Integrative Medicine
San Francisco, California, United States
Countries
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References
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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.
Other Identifiers
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12-09549
Identifier Type: -
Identifier Source: org_study_id