Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea
- Conditions
- ObesityDiabetesObstructive Sleep Apnea
- Interventions
- Registration Number
- NCT02069197
- Lead Sponsor
- Mid-Atlantic Epilepsy and Sleep Center, LLC
- Brief Summary
The purpose of the study is to evaluate the efficacy and safety of ketogenic diet (KD) treatment of (i) obesity, (ii) type 2 diabetes mellitus and (iii) obstructive sleep apnea (OSA) in patients with obesity and Type 2 DM and in patients with obesity and/or OSA. This will be a randomized, open-label three arm controlled study comparing weight loss in obese participants with type 2 diabetes and/or obstructive sleep apnea treated for 9 months with 3:1 \[fat\]:\[protein+carbohydrate\] ratio, 1600 kcal/day diet (Group A) with weight loss in participants treated with orlistat 120 mg TID and lifestyle intervention consisting of dietary advice, recommended caloric goal of 1600 kcal/day (Group B), and in participants treated with only lifestyle intervention consisting of dietary advice, recommended caloric goal of 1600 kcal/day (Group C).
- Detailed Description
The study sample will be randomized into three treatment arms, KD (Group A, n=50), Orlistat 120 mg TID (Group B, n=50) and dietary and lifestyle counseling (Group C, n=50) in a 1:1:1 ratio. Each arm will include 100% participants with obesity and co-morbid type 2 DM and 50% participants with co-morbid OSA. Randomization will be stratified for diabetic status.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- age 18-70
- 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.
- BMI change of +/- 3.0 kg/m2 of baseline BMI within past 12 months.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Ketogenic diet, lifestyle counseling Ketogenic diet ketogenic diet consisted of 3:1\[fat\]:\[protein+carbohydrate\] weight ratio with 1600kcal restriction. Standartized diet, Lifestyle counseling Standardized diet Standardized diet and lifestyle-modification counseling based on the LEARN (Lifestyle, Exercise, Attitudes, Relationship, Nutrition) program with recommended caloric goal of 1600kcal/day. Orlistat, Lifestyle counseling Orlistat 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.
- Primary Outcome Measures
Name Time Method Change of body mass index from baseline in 9 months period 9 months The change of weight and the BMI(body mass index) will be calculated.
- Secondary Outcome Measures
Name Time Method Change from baseline in glucose blood level in patients with diabetes mellitus in 9 months. 9 months HbA1C, fasting serum glucose insulin and leptin levels and fasting lipid levels
Change of apnea/hypopnea index in patients with obstructive sleep apnea in patients with obesity 9 months For participants with OSA, secondary outcome will include polysomnogram-derived apnea/hypopnea index.
Level of alertness will be evaluated with Epworth Sleepiness Scale.To evaluate safety of ketogenic diet as a treatment of obesity. 9 months Evaluate in serum levels of beta-hydroxybutyrate, glucose, electrolytes, renal and liver functions, uric acid, HbA1C, serum lipid profile, insulin and leptin levels, CRP.
Trial Locations
- Locations (1)
Mid-Atlantic Epilepsy and Sleep Center, LLC
🇺🇸Bethesda, Maryland, United States