Deciphering the Role of Incretin Hormones in Weight Loss-induced Remission of Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Number of participants with incretin effect's restoration after achieving weightloss-induced diabetes remission
研究概览
简要总结
The goal of this mechanistic study is to investigate the role of incretin hormones on weight loss-induced type 2 diabetes remission.
详细描述
Participants will undergo an intensive, individualized dietary treatment to achieve a 10% reduction in body weight, during which glucose-lowering therapy will be withdrawn. Before and after the intervention, the patients will undergo:
- measurement of fasting glucose and glycated hemoglobin
- Indirect calorimetry
- oral glucose tolerance test
- intravenous glucose tolerance test
- quality of life and diet-related questionnaires
- 72-hour food records
At the end of the protocol, subjects will be followed up to maintain lifestyle changes and intercept cases of diabetes relapse.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T2D for less than 6 years;
- •age 18-65 years;
- •both genders;
- •BMI 27-45 kg/m2;
- •HbA1c 48-108 mmol/mol (43-108 mmol/mol if on glucose-lowering drugs).
排除标准
- •type 1 or secondary/genetic diabetes;
- •treatment with insulin, Glucagon-Like Peptide-1 agonists, Gastric Inhibitory Peptide/GLP-1 co-agonists, or pioglitazone;
- •weight loss >5% within the previous 6 months;
- •eGFR <30 ml/min/1.73m2;
- •myocardial infarction within the previous 6 months;
- •severe heart failure (NYHA III-IV); eating disorder; substance abuse;
- •severe depression;
- •known cancer;
- •pregnancy.
研究组 & 干预措施
Obese subjects with type 2 diabetes mellitus
Individualized weight-loss nutritional intervention
干预措施: Weight loss-induced Diabetes Remission (Behavioral)
结局指标
主要结局
Number of participants with incretin effect's restoration after achieving weightloss-induced diabetes remission
时间窗: 12 weeks
The investigators will test whether diabetes remission obtained after 10% weight-loss, induced by an intensive nutritional intervention, is associated with an improvement of the incretin effect from baseline. Diabetes remission will be defined according to the latest international consensus as an HbA1c \<48 mmol/mol measured at least 3 months after cessation of glucose-lowering pharmacotherapy. The restoration of the incretin effect will be assessed by measuring both incretin levels and estimated incretin mediated insulin secretion before and after achieving the weight loss during an Oral Glucose Tolerance Test followed by an intravenous Glucose Tolerance Test.
次要结局
- Rate of sustained weightloss-induced diabetes remission assessed by 2 consecutive HbA1c <48mmol/mol within 6 months(36 weeks)
研究者
Andrea Natali
Professor
Azienda Ospedaliero, Universitaria Pisana