Status:
COMPLETED
Prospective Metabolic Surgery in T2DM Chinese Subjects
Lead Sponsor:
Ethicon Endo-Surgery
Conditions:
Diabetes
Obesity
Eligibility:
All Genders
20-60 years
Phase:
NA
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 po...
Eligibility Criteria
Inclusion
- 20 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 31 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2021
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT02217943
Start Date
July 31 2014
End Date
April 11 2021
Last Update
March 30 2025
Active Locations (6)
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1
Beijing Shijitan Hospital
Beijing, China
2
China-Japan Union Hospital of Jilin University
Changchun, China
3
Guangzhou Overseas Chinese Hospital
Guangzhou, China
4
Jiangsu Province Hospital
Jiangsu, China