Prospective Metabolic Surgery in T2DM Chinese Subjects

Ethicon Endo-Surgery101 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

101

Conditions

Diabetes Obesity

Interventions

Roux-en-Y gastric bypassPROCEDURE

Sleeve gastrectomyPROCEDURE

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (6)

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

Outcomes

Primary Outcomes

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;

Time frame: 2 years

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;

Time frame: 2 years

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;

Time frame: 2 years

Composite Measure of Glycemic Control - Unchanged

The absence of remission or improvement as described earlier;

Time frame: 2 years

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.

Time frame: 2 years

Secondary Outcomes

Composite Measure of Glycemic Control

The composite measure of glycemic control will be defined as previously described in the primary outcome measure.

Time frame: 5 years

Data from ClinicalTrials.gov

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