Evaluation of Efficacy and Safety of Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea.
Overview
- Phase
- Phase 2
- Intervention
- Ketogenic diet
- Conditions
- Obesity
- Sponsor
- Mid-Atlantic Epilepsy and Sleep Center, LLC
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Change of body mass index from baseline in 9 months period
- Last Updated
- 7 years ago
Overview
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.
Investigators
Pavel Klein
MD
Mid-Atlantic Epilepsy and Sleep Center, LLC
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Ketogenic diet, lifestyle counseling
ketogenic diet consisted of 3:1\[fat\]:\[protein+carbohydrate\] weight ratio with 1600kcal restriction.
Intervention: Ketogenic diet
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.
Intervention: Orlistat
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.
Intervention: Standardized diet
Outcomes
Primary Outcomes
Change of body mass index from baseline in 9 months period
Time Frame: 9 months
The change of weight and the BMI(body mass index) will be calculated.
Secondary Outcomes
- Change from baseline in glucose blood level in patients with diabetes mellitus in 9 months.(9 months)
- Change of apnea/hypopnea index in patients with obstructive sleep apnea in patients with obesity(9 months)
- To evaluate safety of ketogenic diet as a treatment of obesity.(9 months)