Overview

This trial is active, not recruiting.

Conditions diabetes, obesity
Treatments roux-en-y gastric bypass, sleeve gastrectomy
Sponsor Ethicon Endo-Surgery
Start date July 2014
End date July 2018
Trial size 101 participants
Trial identifier NCT02217943, ESC-14-002

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Subjects who receive a Roux-en-Y gastric bypass
roux-en-y gastric bypass
(Active Comparator)
Subjects who receive a sleeve gastrectomy
sleeve gastrectomy

Primary Outcomes

Measure
Composite Measure of Glycemic Control - Complete Remission
time frame: 2 years
Composite Measure of Glycemic Control - Partial remission
time frame: 2 years
Composite Measure of Glycemic Control - Improvement
time frame: 2 years
Composite Measure of Glycemic Control - Unchanged
time frame: 2 years
Composite Measure of Glycemic Control - Recurrence
time frame: 2 years

Secondary Outcomes

Measure
Composite Measure of Glycemic Control
time frame: 5 years
Evaluation of diabetic nephropathy
time frame: 5 years
Evaluation of diabetic retinopathy
time frame: 5 years
Assess changes in HbA1c
time frame: 5 years
Assess changes in Weight (kg)
time frame: 5 years
Assess changes in BMI
time frame: 5 years
Assess changes in high-density lipoprotein (HDL) (mg/dL and mmol/L)
time frame: 5 years
Assess changes in low-density lipoprotein (LDL) (mg/dL and mmol/L
time frame: 5 years
Assess changes in triglycerides (TG) (mg/dL and mmol/L)
time frame: 5 years
Assess changes in cholesterol (mg/dL and mmol/L)
time frame: 5 years
Assess changes in FPG (mg/dL and mmol/L)
time frame: 5 years
Assess changes in insulin (µU/mL and pmol/L)
time frame: 5 years
Assess changes in serum albumin level (g/L)
time frame: 5 years
Assess changes in alanine aminotransferase (ALT) level (Unit [U]/L)
time frame: 5 years
Assess changes in aspartate aminotransferase (AST) level (U/L)
time frame: 5 years
Assess changes in gamma-glutamyl transferase (GGT) level (U/L)
time frame: 5 years
Assess changes in creatinine levels (mg/dL and mmol/L)
time frame: 5 years
Assess changes in blood urea nitrogen (BUN) levels (mg/dL and mmol/L)
time frame: 5 years
Assess changes in anti-hypertensive medication
time frame: 5 years
Asses the changes in lipid lowering medication
time frame: 5 years
Assess the changes in hyperglycemia medication
time frame: 5 years
Assess the changes in SF-36 Health Survey
time frame: 5 years

Eligibility Criteria

Male or female participants from 20 years up to 60 years old.

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.

Additional Information

Official title A Prospective, Multi-Center Study for the Evaluation of Metabolic Surgery in Subjects With Type 2 Diabetes in China
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Ethicon Endo-Surgery.