Prospective Metabolic Surgery in T2DM Chinese Subjects

Ethicon

Status: Completed

Conditions: Diabetes; Obesity

Treatments: Procedure: Sleeve gastrectomy; Procedure: Roux-en-Y gastric bypass

Study type: Interventional

Funder types: Industry

Identifiers

NCT02217943

ESC-14-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

101 participants in 2 patient groups

Roux-en-Y gastric bypass

Active Comparator group

Description:

Subjects who receive a Roux-en-Y gastric bypass

Treatment:

Procedure: Roux-en-Y gastric bypass

Sleeve Gastrectomy

Active Comparator group

Description:

Subjects who receive a sleeve gastrectomy

Treatment:

Procedure: Sleeve gastrectomy