Prospective Metabolic Surgery in T2DM Chinese Subjects

Obesity Clinical Trial

Official title:

A Prospective, Multi-Center Study for the Evaluation of Metabolic Surgery in Subjects With Type 2 Diabetes in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02217943
• Other study ID #: ESC-14-002
• Status: Completed
• Phase: N/A
• Start date: July 1, 2014
• Est. completion date: April 11, 2021

Study information

• Verified date: June 2023
• Source: Ethicon Endo-Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: April 11, 2021
• Est. primary completion date: June 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

Procedure:
• Roux-en-Y gastric bypass

• Sleeve gastrectomy

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Composite Measure of Glycemic Control - Unchanged	The absence of remission or improvement as described earlier;	2 years
Primary	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	Composite Measure of Glycemic Control	The composite measure of glycemic control will be defined as previously described in the primary outcome measure.	5 years
Secondary	Evaluation of diabetic nephropathy	Evaluate long-term diabetic nephropathy	5 years
Secondary	Evaluation of diabetic retinopathy	Evaluate long-term diabetic retinopathy.	5 years
Secondary	Assess changes in HbA1c	Assess changes in HbA1c after the procedure is performed.	5 years
Secondary	Assess changes in Weight (kg)	Assess changes in weight after the procedure is performed.	5 years
Secondary	Assess changes in BMI	Assess changes in BMI after the procedure is performed.	5 years
Secondary	Assess changes in high-density lipoprotein (HDL) (mg/dL and mmol/L)	Assess changes in high-density lipoprotein (HDL) (mg/dL and mmol/L) after the procedure is performed	5 years
Secondary	Assess changes in low-density lipoprotein (LDL) (mg/dL and mmol/L	Assess changes in low-density lipoprotein (LDL) (mg/dL and mmol/L) after the procedure is performed.	5 years
Secondary	Assess changes in triglycerides (TG) (mg/dL and mmol/L)	Assess changes in triglycerides (TG) (mg/dL and mmol/L) after the procedure is performed.	5 years
Secondary	Assess changes in cholesterol (mg/dL and mmol/L)	Assess changes in cholesterol (mg/dL and mmol/L) after the procedure is performed.	5 years
Secondary	Assess changes in FPG (mg/dL and mmol/L)	Assess changes in FPG (mg/dL and mmol/L) after the procedure is performed	5 years
Secondary	Assess changes in insulin (µU/mL and pmol/L)	Assess changes in insulin (µU/mL and pmol/L) after the procedure is performed	5 years
Secondary	Assess changes in serum albumin level (g/L)	Assess changes in serum albumin level (g/L) after the procedure is performed	5 years
Secondary	Assess changes in alanine aminotransferase (ALT) level (Unit [U]/L)	Assess changes in alanine aminotransferase (ALT) level (Unit [U]/L) after the procedure is performed	5 years
Secondary	Assess changes in aspartate aminotransferase (AST) level (U/L)	Assess changes in aspartate aminotransferase (AST) level (U/L) after the procedure is performed	5 years
Secondary	Assess changes in gamma-glutamyl transferase (GGT) level (U/L)	Assess changes in gamma-glutamyl transferase (GGT) level (U/L) after the procedure is performed	5 years
Secondary	Assess changes in creatinine levels (mg/dL and mmol/L)	Assess changes in creatinine levels (mg/dL and mmol/L) after the procedure is performed	5 years
Secondary	Assess changes in blood urea nitrogen (BUN) levels (mg/dL and mmol/L)	Assess changes in blood urea nitrogen (BUN) levels (mg/dL and mmol/L) after the procedure is performed	5 years
Secondary	Assess changes in anti-hypertensive medication	Assess changes in anti-hypertensive medication after the procedure is performed	5 years
Secondary	Asses the changes in lipid lowering medication	Asses the changes in lipid lowering medication after the procedure is performed	5 years
Secondary	Assess the changes in hyperglycemia medication	Assess the changes in hyperglycemia medication after the procedure is performed	5 years
Secondary	Assess the changes in SF-36 Health Survey	Assess the changes in SF-36 Health Survey after the procedure is performed	5 years