DiabetesNCT02217943
Prospective Metabolic Surgery in T2DM Chinese Subjects
A study testing Roux-en-Y gastric bypass and Sleeve gastrectomy in people with Diabetes and Obesity, run by Ethicon Endo-Surgery at 6 sites in China.
Trial summary
The primary goal of this study is to assess impact of metabolic surgery on glycemic control in diabetic patients. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- What is being tested?
- Roux-en-Y gastric bypass and Sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 6 sitesChina
- Study dates
- 31 Jul 2014to 11 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Beijing Shijitan Hospital
Beijing
China-Japan Union Hospital of Jilin University
Changchun
Guangzhou Overseas Chinese Hospital
Guangzhou
Jiangsu Province Hospital
Jiangsu
Shanghai East Hospital
Shanghai
Shanghai No. 6 People's Hospital
Shanghai
About this study
Official title: A Prospective, Multi-Center Study for the Evaluation of Metabolic Surgery in Subjects With Type 2 Diabetes in China
The primary goal of this study is to assess impact of metabolic surgery on glycemic control in diabetic patients.
Read the 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.
- Being tested
- Roux-en-Y gastric bypass, Sleeve gastrectomy
- Medical subject headings
- Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y gastric bypassProcedure or surgery
Sleeve gastrectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Roux-en-Y gastric bypass | Active comparator | Subjects who receive a Roux-en-Y gastric bypass Receives: Procedure: Roux-en-Y gastric bypass |
| Sleeve Gastrectomy | Active comparator | Subjects who receive a sleeve gastrectomy Receives: Procedure: Sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 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;
Measured: 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;
Measured: 2 years
Composite Measure of Glycemic Control - Unchanged
The absence of remission or improvement as described earlier;
Measured: 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.
Measured: 2 years
Secondary outcomes (22)
Composite Measure of Glycemic Control
The composite measure of glycemic control will be defined as previously described in the primary outcome measure.
Measured: 5 years
Evaluation of diabetic nephropathy
Evaluate long-term diabetic nephropathy
Measured: 5 years
Evaluation of diabetic retinopathy
Evaluate long-term diabetic retinopathy.
Measured: 5 years
Assess changes in HbA1c
Assess changes in HbA1c after the procedure is performed.
Measured: 5 years
Assess changes in Weight (kg)
Assess changes in weight after the procedure is performed.
Measured: 5 years
Assess changes in BMI
Assess changes in BMI after the procedure is performed.
Measured: 5 years
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
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
Assess changes in cholesterol (mg/dL and mmol/L)
Assess changes in cholesterol (mg/dL and mmol/L) after the procedure is performed.
Measured: 5 years
Assess changes in FPG (mg/dL and mmol/L)
Assess changes in FPG (mg/dL and mmol/L) after the procedure is performed
Measured: 5 years
Assess changes in insulin (µU/mL and pmol/L)
Assess changes in insulin (µU/mL and pmol/L) after the procedure is performed
Measured: 5 years
Assess changes in serum albumin level (g/L)
Assess changes in serum albumin level (g/L) after the procedure is performed
Measured: 5 years
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
Measured: 5 years
Assess changes in aspartate aminotransferase (AST) level (U/L)
Assess changes in aspartate aminotransferase (AST) level (U/L) after the procedure is performed
Measured: 5 years
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
Measured: 5 years
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
Measured: 5 years
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
Measured: 5 years
Assess changes in anti-hypertensive medication
Assess changes in anti-hypertensive medication after the procedure is performed
Measured: 5 years
Asses the changes in lipid lowering medication
Asses the changes in lipid lowering medication after the procedure is performed
Measured: 5 years
Assess the changes in hyperglycemia medication
Assess the changes in hyperglycemia medication after the procedure is performed
Measured: 5 years
Assess the changes in SF-36 Health Survey
Assess the changes in SF-36 Health Survey after the procedure is performed
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study start31 Jul 2014
- Primary completion5 Jun 2018
- Study completion11 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robin Scamuffa, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217943
- Sponsor's protocol ID
- ESC-14-002
- Status last verified
- Mar 2025
- First submitted
- 14 Aug 2014
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center Study for the Evaluation of Metabolic Surgery in Subjects With Type 2 Diabetes in China
- ClinicalTrials.gov ID
- NCT02217943
- Acronym / sponsor ID
- ESC-14-002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2014 (actual)
- Primary completion
- 5 Jun 2018 (actual)
- Study completion
- 11 Apr 2021 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roux-en-Y gastric bypass | Active comparator | Procedure: Roux-en-Y gastric bypassSubjects who receive a Roux-en-Y gastric bypass |
| Sleeve Gastrectomy | Active comparator | Procedure: Sleeve gastrectomySubjects who receive a sleeve gastrectomy |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roux-en-Y gastric bypass | Procedure or surgery | Roux-en-Y gastric bypass |
| Sleeve gastrectomy | Procedure or surgery | Sleeve Gastrectomy |
Primary outcome
Composite Measure of Glycemic Control - Complete Remission
Time frame: 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
Time frame: 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;
Composite Measure of Glycemic Control - Improvement
Time frame: 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 - Unchanged
Time frame: 2 years
The absence of remission or improvement as described earlier;
Composite Measure of Glycemic Control - Recurrence
Time frame: 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.
22 secondary outcomes
Composite Measure of Glycemic Control
Time frame: 5 years
Evaluation of diabetic nephropathy
Time frame: 5 years
Evaluation of diabetic retinopathy
Time frame: 5 years
Assess changes in HbA1c
Time frame: 5 years
Assess changes in Weight (kg)
Time frame: 5 years
Assess changes in BMI
Time frame: 5 years
Assess changes in high-density lipoprotein (HDL) (mg/dL and mmol/L)
Time frame: 5 years
Assess changes in low-density lipoprotein (LDL) (mg/dL and mmol/L
Time frame: 5 years
Assess changes in triglycerides (TG) (mg/dL and mmol/L)
Time frame: 5 years
Assess changes in cholesterol (mg/dL and mmol/L)
Time frame: 5 years
Assess changes in FPG (mg/dL and mmol/L)
Time frame: 5 years
Assess changes in insulin (µU/mL and pmol/L)
Time frame: 5 years
Assess changes in serum albumin level (g/L)
Time frame: 5 years
Assess changes in alanine aminotransferase (ALT) level (Unit [U]/L)
Time frame: 5 years
Assess changes in aspartate aminotransferase (AST) level (U/L)
Time frame: 5 years
Assess changes in gamma-glutamyl transferase (GGT) level (U/L)
Time frame: 5 years
Assess changes in creatinine levels (mg/dL and mmol/L)
Time frame: 5 years
Assess changes in blood urea nitrogen (BUN) levels (mg/dL and mmol/L)
Time frame: 5 years
Assess changes in anti-hypertensive medication
Time frame: 5 years
Asses the changes in lipid lowering medication
Time frame: 5 years
Assess the changes in hyperglycemia medication
Time frame: 5 years
Assess the changes in SF-36 Health Survey
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Scamuffa study director
Ethicon, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roux-en-Y gastric bypass and Sleeve gastrectomy in people with Diabetes and Obesity, run by Ethicon Endo-Surgery at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Measure of Glycemic Control - Complete Remission (time frame: 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.