NCT01167959已完成不适用
Hypothalamic Morphology, Neuronal Activity and Systems Biology in Response to Food Intake in Obese Patients With Type 2 Diabetes Mellitus Compared to Obese and Lean Controls
Leiden University Medical Center1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2009年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Changes in gut hormones
研究概览
简要总结
The purpose of this study is to determine the effect of gastric banding or gastric bypass on hypothalamic morphology and function, gut hormones and systems biology in obese subjects with and without type 2 diabetes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients aged 35-65 years;
- •BMI > 40 kg/m2;
- •BMI > 35 and <40 kg/m2 with co-morbidity, which is expected to improve after surgically-induced weight loss;
- •A history of longstanding obesity (>5 years);
- •Proven failed attempts to lose weight in a conventional way, or primarily successful weight loss with eventual weight regain;
- •Intention to adhere to a postoperative follow-up programme.
排除标准
- •BMI> 50 or body weight > 150 kg (because it is impossible to safely put people above this weight on a standard table for MRI);
- •Subjects with disease related obesity, i.e. Cushing or medication related obesity;
- •Use of medication known to affect glucose or lipid metabolism (i.e. prednisone)
- •Monogenetic diabetes: MODY, Mitochondrial diabetes;
- •LADA (adult-onset latent autoimmune diabetes); detected by c-peptide measurement on screening.
- •Impaired renal function (serum creatinine > 176 μmol/L);
- •Leg ulcers, gangrene.
- •Any genetic or psychiatric disease (e.g. fragile X syndrome, major depression) affecting the brain
- •Any significant chronic disease
- •Renal or hepatic disease
- •Pregnancy
- •Recent weight changes or attempts to loose weight (> 3 kg weight gain or loss, within the last 3 months)
- •Aerobic exercise more that 3 times 60 minutes a week
- •Alcohol consumption of more than 28 units per week at present or in the past
- •Recent blood donation (within the last 2 months)
- •Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year
- •Contra-indications to operative procedures as regular in bariatric surgery
- •Contra-indications to MRI scanning
结局指标
主要结局
Changes in gut hormones
时间窗: 3 weeks
次要结局
未报告次要终点
研究者
Mirjam Anne Lips
drs
Leiden University Medical Center
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Investigation of the Effects of Bariatric Surgery on Taste Reward in HumansObesityNCT01531738Imperial College London22
已完成
4 期
Adjustable Gastric Banding and Its Effects on Postprandial Glucose Metabolism Independent of Weight LossObesityDiabetesNCT01094054Mayo Clinic29
招募中
不适用
Effect of obesity surgery on gastric motility, QOL and glucose metabolismObesityJPRN-UMIN000043300Hyogo College of Medicine Division of Gastroenterology and Hepatology100
进行中（未招募）
不适用
Intestinal Metabolic Reprogramming as a Key Mechanism of Gastric Bypass in HumansEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesDiabetes Mellitus, Type 2ObesityNCT02710370University of Pittsburgh46
已完成
不适用
The Effect of Gastric Bypass Surgery on Gut Hormones Related to Bone Remodeling and Intestinal Growth.Bone LossObesityNCT01700686University of Copenhagen18