A Prospective, Multi-Center Study for the Evaluation of Metabolic Surgery in Subjects With Type 2 Diabetes in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 6
- 主要终点
- Composite Measure of Glycemic Control - Improvement
研究概览
简要总结
The primary goal of this study is to assess impact of metabolic surgery on glycemic control in diabetic patients.
详细描述
The primary objective of this study is to assess the impact of metabolic surgery (Roux-en-Y gastric bypass [RYGB] or sleeve gastrectomy [SG]) on composite measure of glycemic control at 2 years post surgery in a Type 2 Diabetes Mellitus (T2DM) cohort of subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 to 60 years of age (inclusive) on the date the informed consent document (ICD) is signed;
- •A body mass index (BMI) from 28 kg/m2 to 50 kg/m2 ;
- •Previously diagnosed for at least 6 months with T2DM according to World Health Organization (WHO) criteria;
- •C-peptide > 1 ng/mL (0.3 nmol/L);
- •Able and willing to comply with procedures required by the protocol; and
- •Able to comprehend and sign or, if illiterate, leave their thumb impression on the study ICD.
排除标准
- •History of T2DM for a duration > 10 years;
- •History of drug and/or alcohol abuse within 2 years of Screening Visit;
- •Any previous major GI surgery (e.g., any GI surgery with a resection, etc.). Previous GI surgery allowed include: appendectomy, gall bladder surgery, liver biopsies, and endoscopic procedures;
- •Scheduled concurrent surgical, non-endoscopy, procedure from Visit 1 through the end of Visit 3;
- •Women of childbearing potential who are pregnant or lactating at the time of screening, at the time of surgery, or planning to become pregnant one year or sooner after the surgery;
- •Psychiatric disorders that may affect compliance with the clinical study, including dementia, active psychosis, severe depression, or history of suicide attempts;
- •Any of the following conditions:
- •Inflammatory diseases of the GI tract, including severe intractable esophagitis, gastric ulceration, duodenal ulceration, or specific inflammation such as Crohn's disease or ulcerative colitis that have been active within the past 10 years;
- •End stage renal disease;
- •Abnormal results from glutamic acid decarboxylase autoantibodies (GADA) or protein tyrosine phosphatase-like protein (IA-2A) testing; or
- •Immunocompromised such as that resulting from chronic oral steroid use, cancer chemotherapeutic agents, or immune deficiency disorders;
- •Participation in any other clinical study (not to include registries or survey-only studies) within 30-days or 5 half-lives of an investigational drug (which ever is longer), of Visit 1 (Screening Visit) and for the duration of the study.
结局指标
主要结局
Composite Measure of Glycemic Control - Improvement
时间窗: 2 years
Significant reduction in HbA1c (by \> 1%) or FPG (\> 25 mg/dL \[1.4 mmol/L\]) OR reduction in HbA1c and FPG accompanied by a decrease in antidiabetic medication requirement (by discontinuing insulin or 1 oral agent, or ½ reduction in dose) for at least 1-year duration;
Composite Measure of Glycemic Control - Unchanged
时间窗: 2 years
The absence of remission or improvement as described earlier;
Composite Measure of Glycemic Control - Recurrence
时间窗: 2 years
FPG or HbA1c in the diabetic range (≥ 126 mg/dL \[7.0 mmol/L\] and ≥ 6.5% \[7.8 mmol/L\], respectively) OR need for antidiabetic medication after initial complete or partial remission.
Composite Measure of Glycemic Control - Complete Remission
时间窗: 2 years
Normal measures of glucose metabolism (glycosylated hemoglobin A1c \[HbA1c\] \< 6% \[7.0 mmol/L\] and fasting plasma glucose \[FPG\] \< 100 mg/dL \[5.6 mmol/L\]) for 1 year in the absence of antidiabetic medications;
Composite Measure of Glycemic Control - Partial remission
时间窗: 2 years
Hyperglycemia (HbA1c 6% - 6.4% \[7.0 - 7.6 mmol/L\] and FPG 100 - 125 mg/dL \[5.6 mmol/L - 6.9 mmol/L\]) for 1 year in the absence of anti-diabetic medications;
次要结局
- Assess the changes in hyperglycemia medication(5 years)
- Composite Measure of Glycemic Control(5 years)
- Assess changes in HbA1c(5 years)
- Assess changes in FPG (mg/dL and mmol/L)(5 years)
- Assess changes in blood urea nitrogen (BUN) levels (mg/dL and mmol/L)(5 years)
- Evaluation of diabetic nephropathy(5 years)
- Assess changes in high-density lipoprotein (HDL) (mg/dL and mmol/L)(5 years)
- Assess changes in low-density lipoprotein (LDL) (mg/dL and mmol/L(5 years)
- Assess changes in cholesterol (mg/dL and mmol/L)(5 years)
- Assess changes in insulin (µU/mL and pmol/L)(5 years)
- Asses the changes in lipid lowering medication(5 years)
- Evaluation of diabetic retinopathy(5 years)
- Assess changes in triglycerides (TG) (mg/dL and mmol/L)(5 years)
- Assess changes in anti-hypertensive medication(5 years)
- Assess changes in alanine aminotransferase (ALT) level (Unit [U]/L)(5 years)
- Assess changes in creatinine levels (mg/dL and mmol/L)(5 years)
- Assess changes in Weight (kg)(5 years)
- Assess changes in BMI(5 years)
- Assess changes in serum albumin level (g/L)(5 years)
- Assess changes in aspartate aminotransferase (AST) level (U/L)(5 years)
- Assess changes in gamma-glutamyl transferase (GGT) level (U/L)(5 years)
- Assess the changes in SF-36 Health Survey(5 years)