Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea
NCT ID: NCT02069197
Last Updated: 2018-08-17
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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UNKNOWN
PHASE2
150 participants
INTERVENTIONAL
2014-01-31
2020-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Ketogenic diet, lifestyle counseling
ketogenic diet consisted of 3:1\[fat\]:\[protein+carbohydrate\] weight ratio with 1600kcal restriction.
Ketogenic diet
ketogenic diet will consist of 3:1\[fat\]:\[protein+carbohydrate\]weight ratio with 1600 kcal restriction. Diet will last 9 months.
Orlistat, Lifestyle counseling
Orlistat 120 mg TID, standardized diet and lifestyle-modification counseling based on the LEARN (Life, Exercise, Attitudes, Relationships,and Nutrition) program with recommended caloric goal of 1600 kcal/day.
Orlistat
Orlistat 120 mg TID for 9 months; life style intervention with recommended caloric goal of 1600 kcal/day.
Standartized diet, Lifestyle counseling
Standardized diet and lifestyle-modification counseling based on the LEARN (Lifestyle, Exercise, Attitudes, Relationship, Nutrition) program with recommended caloric goal of 1600kcal/day.
Standardized diet
Standardized diet treatment for 9 months with recommended caloric goal of 1600kcal/day.
Interventions
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Ketogenic diet
ketogenic diet will consist of 3:1\[fat\]:\[protein+carbohydrate\]weight ratio with 1600 kcal restriction. Diet will last 9 months.
Orlistat
Orlistat 120 mg TID for 9 months; life style intervention with recommended caloric goal of 1600 kcal/day.
Standardized diet
Standardized diet treatment for 9 months with recommended caloric goal of 1600kcal/day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ability and willingness to signed informed consent form
* BMI more than 30kg/m2, with type 2 DM and/or OSA
* For diabetic participants, stable hypoglycemic medications for at least 2 months
* For participants with OSA, previously documented polysomnogram with apnea/hypopnea index (AHI)\>15/h.
Exclusion Criteria
* History of bariatric surgery ≤ 3 years prior to enrollment.
* Any systemic illness or unstable medical condition that might pose additional risk, including: cardiac, unstable metabolic or endocrine disturbances, renal or liver disease, past history of renal calculi, hyperuricemia, hypercalcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, and active systemic cancer.
* History of uncontrolled hyperlipidemia
* For participants with DM, change in the dose or type of hypoglycemic treatment within 2 months prior to enrollment.
* Psychosis within six months of enrollment, evidenced by treatment with anti-psychotic medications with recent medication initiation or dose increase.
* Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators would interfere with adherence to study requirements;
* History of hyperthyroidism
* History of glaucoma
* History of cerebrovascular disease or unstable heart disease within 6 months of enrollment
* Pregnancy
* Use of any investigational drugs within 3 months of enrollment.
* Inability or unwillingness of subject to give written informed consent.
18 Years
70 Years
ALL
No
Sponsors
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Mid-Atlantic Epilepsy and Sleep Center, LLC
OTHER
Responsible Party
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Pavel Klein
MD
Principal Investigators
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Pavel Klein, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mid-Atlantic Epilepsy and Sleep center
Locations
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Mid-Atlantic Epilepsy and Sleep Center, LLC
Bethesda, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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maes 004
Identifier Type: -
Identifier Source: org_study_id
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