Prospective Metabolic Surgery in T2DM Chinese Subjects

NCT02217943 | Completed

• 1 other identifier: ESC-14-002
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Diabetes; Obesity

Outcome Measures

Primary Outcomes (5)

• Composite Measure of Glycemic Control - Complete Remission

  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;

  2 years

• Composite Measure of Glycemic Control - Partial remission

  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;

  2 years

• Composite Measure of Glycemic Control - Improvement

  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;

  2 years

• Composite Measure of Glycemic Control - Unchanged

  The absence of remission or improvement as described earlier;

  2 years

• Composite Measure of Glycemic Control - Recurrence

  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.

  2 years

Secondary Outcomes (22)

• Composite Measure of Glycemic Control

  5 years

• Evaluation of diabetic nephropathy

  5 years

• Evaluation of diabetic retinopathy

  5 years

• Assess changes in HbA1c

  5 years

• Assess changes in Weight (kg)

  5 years

Study Arms (2)

Roux-en-Y gastric bypass

ACTIVE COMPARATOR

Subjects who receive a Roux-en-Y gastric bypass

Procedure: Roux-en-Y gastric bypass

Sleeve Gastrectomy

ACTIVE COMPARATOR

Subjects who receive a sleeve gastrectomy

Procedure: Sleeve gastrectomy

Interventions

Roux-en-Y gastric bypass PROCEDURE

Roux-en-Y gastric bypass

Sleeve gastrectomy PROCEDURE

Sleeve Gastrectomy

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ethicon Endo-Surgery: lead

Study Sites (6)

Beijing Shijitan Hospital

Beijing, China

Location

China-Japan Union Hospital of Jilin University

Changchun, China

Location

Guangzhou Overseas Chinese Hospital

Guangzhou, China

Location

Jiangsu Province Hospital

Jiangsu, China

Location

Shanghai East Hospital

Shanghai, China

Location

Shanghai No. 6 People's Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Diabetes Mellitus; Obesity

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Robin Scamuffa

  Ethicon, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 15, 2014
• Study Start: July 31, 2014
• Primary Completion: June 5, 2018
• Study Completion: April 11, 2021
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

CN (6)