<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02217943</url>
  </required_header>
  <id_info>
    <org_study_id>ESC-14-002</org_study_id>
    <nct_id>NCT02217943</nct_id>
  </id_info>
  <brief_title>Prospective Metabolic Surgery in T2DM Chinese Subjects</brief_title>
  <official_title>A Prospective, Multi-Center Study for the Evaluation of Metabolic Surgery in Subjects With Type 2 Diabetes in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ethicon Endo-Surgery</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ethicon Endo-Surgery</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary goal of this study is to assess impact of metabolic surgery on glycemic control&#xD;
      in diabetic patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to assess the impact of metabolic surgery (Roux-en-Y&#xD;
      gastric bypass [RYGB] or sleeve gastrectomy [SG]) on composite measure of glycemic control at&#xD;
      2 years post surgery in a Type 2 Diabetes Mellitus (T2DM) cohort of subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2014</start_date>
  <completion_date type="Actual">April 11, 2021</completion_date>
  <primary_completion_date type="Actual">June 5, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite Measure of Glycemic Control - Complete Remission</measure>
    <time_frame>2 years</time_frame>
    <description>Normal measures of glucose metabolism (glycosylated hemoglobin A1c [HbA1c] &lt; 6% [7.0 mmol/L] and fasting plasma glucose [FPG] &lt; 100 mg/dL [5.6 mmol/L]) for 1 year in the absence of antidiabetic medications;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite Measure of Glycemic Control - Partial remission</measure>
    <time_frame>2 years</time_frame>
    <description>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;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite Measure of Glycemic Control - Improvement</measure>
    <time_frame>2 years</time_frame>
    <description>Significant reduction in HbA1c (by &gt; 1%) or FPG (&gt; 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;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite Measure of Glycemic Control - Unchanged</measure>
    <time_frame>2 years</time_frame>
    <description>The absence of remission or improvement as described earlier;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite Measure of Glycemic Control - Recurrence</measure>
    <time_frame>2 years</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Composite Measure of Glycemic Control</measure>
    <time_frame>5 years</time_frame>
    <description>The composite measure of glycemic control will be defined as previously described in the primary outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of diabetic nephropathy</measure>
    <time_frame>5 years</time_frame>
    <description>Evaluate long-term diabetic nephropathy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of diabetic retinopathy</measure>
    <time_frame>5 years</time_frame>
    <description>Evaluate long-term diabetic retinopathy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess changes in HbA1c</measure>
    <time_frame>5 years</time_frame>
    <description>Assess changes in HbA1c after the procedure is performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess changes in Weight (kg)</measure>
    <time_frame>5 years</time_frame>
    <description>Assess changes in weight after the procedure is performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess changes in BMI</measure>
    <time_frame>5 years</time_frame>
    <description>Assess changes in BMI after the procedure is performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess changes in high-density lipoprotein (HDL) (mg/dL and mmol/L)</measure>
    <time_frame>5 years</time_frame>
    <description>Assess changes in high-density lipoprotein (HDL) (mg/dL and mmol/L) after the procedure is performed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess changes in low-density lipoprotein (LDL) (mg/dL and mmol/L</measure>
    <time_frame>5 years</time_frame>
    <description>Assess changes in low-density lipoprotein (LDL) (mg/dL and mmol/L) after the procedure is performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess changes in triglycerides (TG) (mg/dL and mmol/L)</measure>
    <time_frame>5 years</time_frame>
    <description>Assess changes in triglycerides (TG) (mg/dL and mmol/L) after the procedure is performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess changes in cholesterol (mg/dL and mmol/L)</measure>
    <time_frame>5 years</time_frame>
    <description>Assess changes in cholesterol (mg/dL and mmol/L) after the procedure is performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess changes in FPG (mg/dL and mmol/L)</measure>
    <time_frame>5 years</time_frame>
    <description>Assess changes in FPG (mg/dL and mmol/L) after the procedure is performed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess changes in insulin (µU/mL and pmol/L)</measure>
    <time_frame>5 years</time_frame>
    <description>Assess changes in insulin (µU/mL and pmol/L) after the procedure is performed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess changes in serum albumin level (g/L)</measure>
    <time_frame>5 years</time_frame>
    <description>Assess changes in serum albumin level (g/L) after the procedure is performed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess changes in alanine aminotransferase (ALT) level (Unit [U]/L)</measure>
    <time_frame>5 years</time_frame>
    <description>Assess changes in alanine aminotransferase (ALT) level (Unit [U]/L) after the procedure is performed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess changes in aspartate aminotransferase (AST) level (U/L)</measure>
    <time_frame>5 years</time_frame>
    <description>Assess changes in aspartate aminotransferase (AST) level (U/L) after the procedure is performed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess changes in gamma-glutamyl transferase (GGT) level (U/L)</measure>
    <time_frame>5 years</time_frame>
    <description>Assess changes in gamma-glutamyl transferase (GGT) level (U/L) after the procedure is performed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess changes in creatinine levels (mg/dL and mmol/L)</measure>
    <time_frame>5 years</time_frame>
    <description>Assess changes in creatinine levels (mg/dL and mmol/L) after the procedure is performed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess changes in blood urea nitrogen (BUN) levels (mg/dL and mmol/L)</measure>
    <time_frame>5 years</time_frame>
    <description>Assess changes in blood urea nitrogen (BUN) levels (mg/dL and mmol/L) after the procedure is performed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess changes in anti-hypertensive medication</measure>
    <time_frame>5 years</time_frame>
    <description>Assess changes in anti-hypertensive medication after the procedure is performed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asses the changes in lipid lowering medication</measure>
    <time_frame>5 years</time_frame>
    <description>Asses the changes in lipid lowering medication after the procedure is performed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the changes in hyperglycemia medication</measure>
    <time_frame>5 years</time_frame>
    <description>Assess the changes in hyperglycemia medication after the procedure is performed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the changes in SF-36 Health Survey</measure>
    <time_frame>5 years</time_frame>
    <description>Assess the changes in SF-36 Health Survey after the procedure is performed</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Diabetes</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Roux-en-Y gastric bypass</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects who receive a Roux-en-Y gastric bypass</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sleeve Gastrectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects who receive a sleeve gastrectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Roux-en-Y gastric bypass</intervention_name>
    <arm_group_label>Roux-en-Y gastric bypass</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sleeve gastrectomy</intervention_name>
    <arm_group_label>Sleeve Gastrectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 20 to 60 years of age (inclusive) on the date the informed consent document (ICD) is&#xD;
             signed;&#xD;
&#xD;
          2. A body mass index (BMI) from 28 kg/m2 to 50 kg/m2 ;&#xD;
&#xD;
          3. Previously diagnosed for at least 6 months with T2DM according to World Health&#xD;
             Organization (WHO) criteria;&#xD;
&#xD;
          4. C-peptide &gt; 1 ng/mL (0.3 nmol/L);&#xD;
&#xD;
          5. Able and willing to comply with procedures required by the protocol; and&#xD;
&#xD;
          6. Able to comprehend and sign or, if illiterate, leave their thumb impression on the&#xD;
             study ICD.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of T2DM for a duration &gt; 10 years;&#xD;
&#xD;
          2. History of drug and/or alcohol abuse within 2 years of Screening Visit;&#xD;
&#xD;
          3. Any previous major GI surgery (e.g., any GI surgery with a resection, etc.). Previous&#xD;
             GI surgery allowed include: appendectomy, gall bladder surgery, liver biopsies, and&#xD;
             endoscopic procedures;&#xD;
&#xD;
          4. Scheduled concurrent surgical, non-endoscopy, procedure from Visit 1 through the end&#xD;
             of Visit 3;&#xD;
&#xD;
          5. Women of childbearing potential who are pregnant or lactating at the time of&#xD;
             screening, at the time of surgery, or planning to become pregnant one year or sooner&#xD;
             after the surgery;&#xD;
&#xD;
          6. Psychiatric disorders that may affect compliance with the clinical study, including&#xD;
             dementia, active psychosis, severe depression, or history of suicide attempts;&#xD;
&#xD;
          7. Any of the following conditions:&#xD;
&#xD;
               1. Inflammatory diseases of the GI tract, including severe intractable esophagitis,&#xD;
                  gastric ulceration, duodenal ulceration, or specific inflammation such as Crohn's&#xD;
                  disease or ulcerative colitis that have been active within the past 10 years;&#xD;
&#xD;
               2. End stage renal disease;&#xD;
&#xD;
               3. Abnormal results from glutamic acid decarboxylase autoantibodies (GADA) or&#xD;
                  protein tyrosine phosphatase-like protein (IA-2A) testing; or&#xD;
&#xD;
               4. Immunocompromised such as that resulting from chronic oral steroid use, cancer&#xD;
                  chemotherapeutic agents, or immune deficiency disorders;&#xD;
&#xD;
          8. Participation in any other clinical study (not to include registries or survey-only&#xD;
             studies) within 30-days or 5 half-lives of an investigational drug (which ever is&#xD;
             longer), of Visit 1 (Screening Visit) and for the duration of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robin Scamuffa</last_name>
    <role>Study Director</role>
    <affiliation>Ethicon, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Shijitan Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China-Japan Union Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangzhou Overseas Chinese Hospital</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital</name>
      <address>
        <city>Jiangsu</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai East Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai No. 6 People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>June 2, 2023</last_update_submitted>
  <last_update_submitted_qc>June 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02217943
org study id: ESC-14-002
nct id: NCT02217943
lead sponsor: 
has dmc: No
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Composite Measure of Glycemic Control - Complete Remission
time frame: 2 years
description: 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;
measure: Composite Measure of Glycemic Control - Partial remission
time frame: 2 years
description: 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;
measure: Composite Measure of Glycemic Control - Improvement
time frame: 2 years
description: 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;
measure: Composite Measure of Glycemic Control - Unchanged
time frame: 2 years
description: The absence of remission or improvement as described earlier;
measure: Composite Measure of Glycemic Control - Recurrence
time frame: 2 years
description: 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.
measure: Composite Measure of Glycemic Control
time frame: 5 years
description: The composite measure of glycemic control will be defined as previously described in the primary outcome measure.
measure: Evaluation of diabetic nephropathy
time frame: 5 years
description: Evaluate long-term diabetic nephropathy
measure: Evaluation of diabetic retinopathy
time frame: 5 years
description: Evaluate long-term diabetic retinopathy.
measure: Assess changes in HbA1c
time frame: 5 years
description: Assess changes in HbA1c after the procedure is performed.
measure: Assess changes in Weight (kg)
time frame: 5 years
description: Assess changes in weight after the procedure is performed.
measure: Assess changes in BMI
time frame: 5 years
description: Assess changes in BMI after the procedure is performed.
measure: Assess changes in high-density lipoprotein (HDL) (mg/dL and mmol/L)
time frame: 5 years
description: Assess changes in high-density lipoprotein (HDL) (mg/dL and mmol/L) after the procedure is performed
measure: Assess changes in low-density lipoprotein (LDL) (mg/dL and mmol/L
time frame: 5 years
description: Assess changes in low-density lipoprotein (LDL) (mg/dL and mmol/L) after the procedure is performed.
measure: Assess changes in triglycerides (TG) (mg/dL and mmol/L)
time frame: 5 years
description: Assess changes in triglycerides (TG) (mg/dL and mmol/L) after the procedure is performed.
measure: Assess changes in cholesterol (mg/dL and mmol/L)
time frame: 5 years
description: Assess changes in cholesterol (mg/dL and mmol/L) after the procedure is performed.
measure: Assess changes in FPG (mg/dL and mmol/L)
time frame: 5 years
description: Assess changes in FPG (mg/dL and mmol/L) after the procedure is performed
measure: Assess changes in insulin (µU/mL and pmol/L)
time frame: 5 years
description: Assess changes in insulin (µU/mL and pmol/L) after the procedure is performed
measure: Assess changes in serum albumin level (g/L)
time frame: 5 years
description: Assess changes in serum albumin level (g/L) after the procedure is performed
measure: Assess changes in alanine aminotransferase (ALT) level (Unit [U]/L)
time frame: 5 years
description: Assess changes in alanine aminotransferase (ALT) level (Unit [U]/L) after the procedure is performed
measure: Assess changes in aspartate aminotransferase (AST) level (U/L)
time frame: 5 years
description: Assess changes in aspartate aminotransferase (AST) level (U/L) after the procedure is performed
measure: Assess changes in gamma-glutamyl transferase (GGT) level (U/L)
time frame: 5 years
description: Assess changes in gamma-glutamyl transferase (GGT) level (U/L) after the procedure is performed
measure: Assess changes in creatinine levels (mg/dL and mmol/L)
time frame: 5 years
description: Assess changes in creatinine levels (mg/dL and mmol/L) after the procedure is performed
measure: Assess changes in blood urea nitrogen (BUN) levels (mg/dL and mmol/L)
time frame: 5 years
description: Assess changes in blood urea nitrogen (BUN) levels (mg/dL and mmol/L) after the procedure is performed
measure: Assess changes in anti-hypertensive medication
time frame: 5 years
description: Assess changes in anti-hypertensive medication after the procedure is performed
measure: Asses the changes in lipid lowering medication
time frame: 5 years
description: Asses the changes in lipid lowering medication after the procedure is performed
measure: Assess the changes in hyperglycemia medication
time frame: 5 years
description: Assess the changes in hyperglycemia medication after the procedure is performed
measure: Assess the changes in SF-36 Health Survey
time frame: 5 years
description: Assess the changes in SF-36 Health Survey after the procedure is performed
arm group label: Roux-en-Y gastric bypass
arm group type: Active Comparator
description: Subjects who receive a Roux-en-Y gastric bypass
arm group label: Sleeve Gastrectomy
arm group type: Active Comparator
description: Subjects who receive a sleeve gastrectomy
intervention type: Procedure
intervention name: Roux-en-Y gastric bypass
arm group label: Roux-en-Y gastric bypass
intervention type: Procedure
intervention name: Sleeve gastrectomy
arm group label: Sleeve Gastrectomy
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Robin Scamuffa
role: Study Director
affiliation: Ethicon, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor