Evaluation of Efficacy and Safety of Ketogenic Complete Meal Replacement as Treatment of Obesity-related Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Type 2 diabetes remission
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of ketogenic diet (KD) complete meal replacement treatment of obesity-related Type 2 diabetes mellitus (T2DM) and of obesity in patients with obesity and T2DM. This will be an open-label single arm study evaluating glycemic control and weight loss in obese participants with type 2 diabetes treated for 6 months with 3:1 [fat]:[protein+carbohydrate] ratio, 1600 kcal/day diet.
详细描述
The purpose of the study is to evaluate the efficacy and safety of ketogenic diet (KD) complete meal replacement treatment of obesity-related Type 2 diabetes mellitus (T2DM) and of obesity in patients with obesity and T2DM. This will be an open-label single arm study evaluating glycemic control and weight loss in obese participants with type 2 diabetes treated for 6 months with 3:1 [fat]:[protein+carbohydrate] ratio, 1600 kcal/day diet.
Treatment will consist of KD complete meal replacement with 3:1 [fat]: [protein + carbohydrate] weight ratio, and with 1600 kcal restriction. It will consist of pre-made meals, including breakfast, lunch, dinner and two snacks, one each between breakfast and lunch and lunch and dinner. Meals will be made according to supplied recipes (Anemone, LLC.) with a 3-week long meal plan consisting of different recipes for the 3 meals and 2 snacks different for each day of the 3-week cycle, with repeating cycles. All KD-treated participants will receive the same meal plan. Meals will be prepared uniformly by one facility and will be delivered to participants frozen once a week in packages subdivided into individual days with each day's package containing 5 separately packaged meals. Participants will be given a list of allowed 0 calories drinks and will consume no non-allowed beverages. Reductions to oral glycemic medications will occur at the start of the diet.
Participants will be evaluated in face-to-face visit during weeks 1, 2 and 4 of the study, then monthly (see Table 1, visit schedule). Evaluations will include weight, BMI, BP, waist circumference, adverse events and treatment compliance. Participants will check their blood glucose levels 3x/day, including am fasting, mid-day and evening 2 hours post-prandial, and urine for ketones levels with Ketostix (Bayer AG, IN, U.S.A.) 2x/day. They will record results in a glucose and ketone level diary which will be reviewed at each visit. Laboratory evaluations will include 8 am serum fasting glucose, insulin levels, C-peptide and lipid panel, HbA1C, serum beta-hydroxybutyrate (BOH), leptin levels, C-reactive protein (CRP), complete blood count (CBC), basic metabolic profile (BMP), renal and liver functions tests (LFTs), and uric acid. Laboratory evaluations will be obtained once at baseline prior to treatment initiation, at 3 and 6 months after treatment initiation. Hunger will be evaluated with a 7-point Likert scale (range: extremely hungry to extremely full) which will be administered at each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Ability and willingness to sign informed consent form.
- •T2D with BMI ≥ 30 kg/m2
- •Stable hypoglycemic medications for at least 2 months
排除标准
- •History of bariatric surgery ≤ 2 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
- •Change in the dose or type of hypoglycemic treatment within 1 month 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 cerebrovascular disease or unstable heart disease within 6 months of enrollment
- •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
3:1 Ketogenic Complete Meal Replacement
Evaluating glycemic control and weight loss in obese participants with type 2 diabetes treated for 6 months with 3:1 [fat]:[protein+carbohydrate] ratio, 1600 kcal/day complete meal replacement ketogenic diet
干预措施: 3:1 ratio Ketogenic diet (Other)
结局指标
主要结局
Type 2 diabetes remission
时间窗: 6 months (study duration)
Defined as normal fasting blood glucose (\<126), normal HbA1C (\<6.4%), and no diabetic medications
次要结局
- Waist circumference(Day 7, Day 14, Month 1, 2, 3, 4, 5 and 6)
- Fasting lipid levels(0, 3 and 6 months treatment duration)
- Weight(Day 0, Day 7, Day 14, Month 1, 2, 3, 4, 5 and 6)
- Change from baseline in glucose blood level in patients with type 2 DM in 6 months.(6 months (study duration))
- Change from baseline in HbA1C in patients with type 2 DM in 6 months.(0, 3 and 6 months treatment duration)
- Adverse events(6 months (study duration))
- Fasting leptin levels(0, 3 and 6 months treatment duration)
- Percentage of diabetic medication load reduction(6 months (study duration))
- Blood pressure(Day 7, Day 14, Month 1, 2, 3, 4, 5 and 6)
- Urine ketone levels(Day 7, Day 14, Month 1, 2, 3, 4, 5 and 6)
- Fasting serum insulin(0, 3 and 6 months treatment duration)
- BMI(Day 0, Day 7, Day 14, Month 1, 2, 3, 4, 5 and 6)
- Hunger scale scores(Day 0, Day 7, Day 14, Month 1, 2, 3, 4, 5 and 6)
研究者
Pavel Klein
Principal Investigator
Mid-Atlantic Epilepsy and Sleep Center, LLC