Prospective Metabolic Surgery in T2DM Chinese Subjects

Not Applicable

Completed

• Conditions: Diabetes; Obesity
• Interventions: Procedure: Roux-en-Y gastric bypass; Procedure: Sleeve gastrectomy

• Registration Number: NCT02217943
• Lead Sponsor: Ethicon Endo-Surgery

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.

Study Timeline

• Study Start: 2014-07-31
• Study First Submitted: 2014-08-14
• Study First Submitted QC: 2014-08-14
• Study First Posted: 2014-08-15
• Primary Completion: 2018-06-05
• Study Completion: 2021-04-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Roux-en-Y gastric bypass	Roux-en-Y gastric bypass	Subjects who receive a Roux-en-Y gastric bypass
Sleeve Gastrectomy	Sleeve gastrectomy	Subjects who receive a sleeve gastrectomy

Primary Outcome Measures

Name	Time	Method
Composite Measure of Glycemic Control - Unchanged	2 years	The absence of remission or improvement as described earlier;
Composite Measure of Glycemic Control - Improvement	2 years	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;
Composite Measure of Glycemic Control - Recurrence	2 years	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.
Composite Measure of Glycemic Control - Complete Remission	2 years	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;
Composite Measure of Glycemic Control - Partial remission	2 years	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;

Secondary Outcome Measures

Name	Time	Method
Assess changes in Weight (kg)	5 years	Assess changes in weight after the procedure is performed.
Assess the changes in hyperglycemia medication	5 years	Assess the changes in hyperglycemia medication after the procedure is performed
Composite Measure of Glycemic Control	5 years	The composite measure of glycemic control will be defined as previously described in the primary outcome measure.
Assess changes in HbA1c	5 years	Assess changes in HbA1c after the procedure is performed.
Assess changes in FPG (mg/dL and mmol/L)	5 years	Assess changes in FPG (mg/dL and mmol/L) after the procedure is performed
Assess changes in blood urea nitrogen (BUN) levels (mg/dL and mmol/L)	5 years	Assess changes in blood urea nitrogen (BUN) levels (mg/dL and mmol/L) after the procedure is performed
Evaluation of diabetic nephropathy	5 years	Evaluate long-term diabetic nephropathy
Assess changes in high-density lipoprotein (HDL) (mg/dL and mmol/L)	5 years	Assess changes in high-density lipoprotein (HDL) (mg/dL and mmol/L) after the procedure is performed
Assess changes in low-density lipoprotein (LDL) (mg/dL and mmol/L	5 years	Assess changes in low-density lipoprotein (LDL) (mg/dL and mmol/L) after the procedure is performed.
Assess changes in cholesterol (mg/dL and mmol/L)	5 years	Assess changes in cholesterol (mg/dL and mmol/L) after the procedure is performed.
Assess changes in insulin (µU/mL and pmol/L)	5 years	Assess changes in insulin (µU/mL and pmol/L) after the procedure is performed
Asses the changes in lipid lowering medication	5 years	Asses the changes in lipid lowering medication after the procedure is performed
Evaluation of diabetic retinopathy	5 years	Evaluate long-term diabetic retinopathy.
Assess changes in triglycerides (TG) (mg/dL and mmol/L)	5 years	Assess changes in triglycerides (TG) (mg/dL and mmol/L) after the procedure is performed.
Assess changes in anti-hypertensive medication	5 years	Assess changes in anti-hypertensive medication after the procedure is performed
Assess changes in alanine aminotransferase (ALT) level (Unit [U]/L)	5 years	Assess changes in alanine aminotransferase (ALT) level (Unit \[U\]/L) after the procedure is performed
Assess changes in creatinine levels (mg/dL and mmol/L)	5 years	Assess changes in creatinine levels (mg/dL and mmol/L) after the procedure is performed
Assess changes in BMI	5 years	Assess changes in BMI after the procedure is performed.
Assess changes in serum albumin level (g/L)	5 years	Assess changes in serum albumin level (g/L) after the procedure is performed
Assess changes in aspartate aminotransferase (AST) level (U/L)	5 years	Assess changes in aspartate aminotransferase (AST) level (U/L) after the procedure is performed
Assess changes in gamma-glutamyl transferase (GGT) level (U/L)	5 years	Assess changes in gamma-glutamyl transferase (GGT) level (U/L) after the procedure is performed
Assess the changes in SF-36 Health Survey	5 years	Assess the changes in SF-36 Health Survey after the procedure is performed

Trial Locations

Locations (6)

Jiangsu Province Hospital; 🇨🇳 Jiangsu, China

Beijing Shijitan Hospital; 🇨🇳 Beijing, China

China-Japan Union Hospital of Jilin University; 🇨🇳 Changchun, China

Guangzhou Overseas Chinese Hospital; 🇨🇳 Guangzhou, China

Shanghai No. 6 People's Hospital; 🇨🇳 Shanghai, China

Shanghai East Hospital; 🇨🇳 Shanghai, China