Prospective Metabolic Surgery in T2DM Chinese Subjects

NCT ID: NCT02217943

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2021-04-11

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.

Conditions

Diabetes; Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Roux-en-Y gastric bypass

Subjects who receive a Roux-en-Y gastric bypass

Group Type: ACTIVE_COMPARATOR

Roux-en-Y gastric bypass

Intervention Type: PROCEDURE

Sleeve Gastrectomy

Subjects who receive a sleeve gastrectomy

Group Type: ACTIVE_COMPARATOR

Sleeve gastrectomy

Intervention Type: PROCEDURE

Interventions

Roux-en-Y gastric bypass

Intervention Type: PROCEDURE

Sleeve gastrectomy

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon Endo-Surgery

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robin Scamuffa

Role: STUDY_DIRECTOR

Ethicon, Inc.

Locations

Beijing Shijitan Hospital

Beijing, , China

China-Japan Union Hospital of Jilin University

Changchun, , China

Guangzhou Overseas Chinese Hospital

Guangzhou, , China

Jiangsu Province Hospital

Jiangsu, , China

Shanghai East Hospital

Shanghai, , China

Shanghai No. 6 People's Hospital

Shanghai, , China

Countries

China

Other Identifiers

ESC-14-002

Identifier Type: -

Identifier Source: org_study_id