Evaluation of Efficacy and Safety of Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea.
试验速览
- 阶段
- 2 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change of body mass index from baseline in 9 months period
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Ketogenic diet, lifestyle counseling
ketogenic diet consisted of 3:1[fat]:[protein+carbohydrate] weight ratio with 1600kcal restriction.
干预措施: Ketogenic diet (Other)
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.
干预措施: Orlistat (Drug)
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.
干预措施: Standardized diet (Other)
结局指标
主要结局
Change of body mass index from baseline in 9 months period
时间窗: 9 months
The change of weight and the BMI(body mass index) will be calculated.
次要结局
- 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)
研究者
Pavel Klein
MD
Mid-Atlantic Epilepsy and Sleep Center, LLC