Clinical trial NCT02217943: Prospective Metabolic Surgery in T2DM Chinese Subjects
Official title: A Prospective, Multi-Center Study for the Evaluation of Metabolic Surgery in Subjects With Type 2 Diabetes in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Obesity
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2014-08-15
Enrollment: 101
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary goal of this study is to assess impact of metabolic surgery on glycemic control in diabetic patients.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 20 to 60 years of age (inclusive) on the date the informed consent document (ICD) is signed;
2. A body mass index (BMI) from 28 kg/m2 to 50 kg/m2 ;
3. Previously diagnosed for at least 6 months with T2DM according to World Health Organization (WHO) criteria;
4. C-peptide \> 1 ng/mL (0.3 nmol/L);
5. Able and willing to comply with procedures required by the protocol; and
6. Able to comprehend and sign or, if illiterate, leave their thumb impression on the study ICD.

Exclusion Criteria:

1. History of T2DM for a duration \> 10 years;
2. History of drug and/or alcohol abuse within 2 years of Screening Visit;
3. 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;
4. Scheduled concurrent surgical, non-endoscopy, procedure from Visit 1 through the end of Visit 3;
5. 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;
6. Psychiatric disorders that may affect compliance with the clinical study, including dementia, active psychosis, severe depression, or history of suicide attempts;
7. Any of the following conditions:

   1. 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;
   2. End stage renal disease;
   3. Abnormal results from glutamic acid decarboxylase autoantibodies (GADA) or protein tyrosine phosphatase-like protein (IA-2A) testing; or
   4. Immunocompromised such as that resulting from chronic oral steroid use, cancer chemotherapeutic agents, or immune deficiency disorders;
8. 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.

Primary outcomes:
measure: Composite Measure of Glycemic Control - Complete Remission
timeFrame: 2 years
measure: Composite Measure of Glycemic Control - Partial remission
timeFrame: 2 years
measure: Composite Measure of Glycemic Control - Improvement
timeFrame: 2 years
measure: Composite Measure of Glycemic Control - Unchanged
timeFrame: 2 years
measure: Composite Measure of Glycemic Control - Recurrence
timeFrame: 2 years
Secondary outcomes:
measure: Composite Measure of Glycemic Control
timeFrame: 5 years
measure: Evaluation of diabetic nephropathy
timeFrame: 5 years
measure: Evaluation of diabetic retinopathy
timeFrame: 5 years
measure: Assess changes in HbA1c
timeFrame: 5 years
measure: Assess changes in Weight (kg)
timeFrame: 5 years
measure: Assess changes in BMI
timeFrame: 5 years
measure: Assess changes in high-density lipoprotein (HDL) (mg/dL and mmol/L)
timeFrame: 5 years
measure: Assess changes in low-density lipoprotein (LDL) (mg/dL and mmol/L
timeFrame: 5 years
measure: Assess changes in triglycerides (TG) (mg/dL and mmol/L)
timeFrame: 5 years
measure: Assess changes in cholesterol (mg/dL and mmol/L)
timeFrame: 5 years
measure: Assess changes in FPG (mg/dL and mmol/L)
timeFrame: 5 years
measure: Assess changes in insulin (µU/mL and pmol/L)
timeFrame: 5 years
measure: Assess changes in serum albumin level (g/L)
timeFrame: 5 years
measure: Assess changes in alanine aminotransferase (ALT) level (Unit [U]/L)
timeFrame: 5 years
measure: Assess changes in aspartate aminotransferase (AST) level (U/L)
timeFrame: 5 years
measure: Assess changes in gamma-glutamyl transferase (GGT) level (U/L)
timeFrame: 5 years
measure: Assess changes in creatinine levels (mg/dL and mmol/L)
timeFrame: 5 years
measure: Assess changes in blood urea nitrogen (BUN) levels (mg/dL and mmol/L)
timeFrame: 5 years
measure: Assess changes in anti-hypertensive medication
timeFrame: 5 years
measure: Asses the changes in lipid lowering medication
timeFrame: 5 years
measure: Assess the changes in hyperglycemia medication
timeFrame: 5 years
measure: Assess the changes in SF-36 Health Survey
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Shijitan Hospital
city: Changchun
country: China
facility: China-Japan Union Hospital of Jilin University
city: Guangzhou
country: China
facility: Guangzhou Overseas Chinese Hospital
city: Jiangsu
country: China
facility: Jiangsu Province Hospital
city: Shanghai
country: China
facility: Shanghai East Hospital
city: Shanghai
country: China
facility: Shanghai No. 6 People's Hospital
Study officials:
affiliation: Ethicon, Inc.
name: Robin Scamuffa
role: STUDY_DIRECTOR
References: