NCT00641251

Brief Summary

The present study is the first stage of a research program whose ultimate goal is to conduct a randomized clinical trial involving type 2 diabetics with BMI from 30.0 to 39.9 kg/m2. This program will determine the relative effectiveness of RYGB combined with intensive medical management (IMM), versus IMM alone, in reducing CVD event rates and mortality in patients with poorly controlled diabetes. IMM will include rigorous lifestyle modification for weight loss and stepped pharmacologic treatment for diabetes and other CVD risk factors. The proposed study is a randomized trial which will provide an assessment of the efficacy of treatment, in reducing CVD risk factors and also assessing the feasibility, cost, and safety of a larger trial.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Feb 2008

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

8.8 years

First QC Date

February 13, 2008

Last Update Submit

November 27, 2017

Conditions

Type 2 DiabetesCardiovascular Disease

Keywords

T2 DiabetesType 2 diabetes CVD event rates and mortality

Outcome Measures

Primary Outcomes (3)

  • HbA1c < 7.0%

    12 Months

  • Systolic blood pressure < 130 mm Hg

    12 Months

  • LDL cholesterol < 100 mg/dl

    12 Months

Study Arms (2)

1

ACTIVE COMPARATOR

intensive medical management

Other: intensive medical management

2

ACTIVE COMPARATOR

Roux-en-Y gastric bypass with intensive medical management

Other: RYGB & IMM

Interventions

intensive medical managementOTHER

IMM will include rigorous lifestyle modification for weight loss and stepped pharmacologic treatment consistent with standard of care for diabetes and other CVD risk factors.

1
RYGB & IMMOTHER

Roux-en-Y gastric bypass Surgery combined with intensive medical management

2

Eligibility Criteria

Age30 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 30 to 67 years at eligibility visit.
  • Diagnosed with T2DM at least 6 months prior to enrollment, under the active care of a doctor for at least the six months prior to enrollment, and HbA1c ≥ 8.0 %.
  • Body Mass Index (BMI) ≥ 30.0 kg/m2 and ≤ 39.9 kg/m2 at eligibility visit.
  • Willingness to accept random assignment to either treatment group.
  • Expect to live or work within approximately one hour's traveling time from the study clinic for the duration of the two-year trial.
  • Willingness to comply with the follow-up protocol and successful completion of the run-in (described below).
  • Written informed consent.

You may not qualify if:

  • Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
  • Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.
  • Cardiac stress test indicating that surgery or IMM would not be safe.
  • Pulmonary embolus or thrombophlebitis in the past six months.
  • Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years.
  • Significant anemia (hemoglobin 1.0 g or more below normal range) or history of coagulopathy.
  • Serum creatinine ≥ 1.5 mg/dl.
  • HbA1c \> 14.0%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Min-Sheng General Hospital

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (5)

  • Ikramuddin S, Korner J, Lee WJ, Thomas AJ, Connett JE, Bantle JP, Leslie DB, Wang Q, Inabnet WB 3rd, Jeffery RW, Chong K, Chuang LM, Jensen MD, Vella A, Ahmed L, Belani K, Billington CJ. Lifestyle Intervention and Medical Management With vs Without Roux-en-Y Gastric Bypass and Control of Hemoglobin A1c, LDL Cholesterol, and Systolic Blood Pressure at 5 Years in the Diabetes Surgery Study. JAMA. 2018 Jan 16;319(3):266-278. doi: 10.1001/jama.2017.20813.

    PMID: 29340678DERIVED

  • Chong K, Ikramuddin S, Lee WJ, Billington CJ, Bantle JP, Wang Q, Thomas AJ, Connett JE, Leslie DB, Inabnet WB 3rd, Jeffery RW, Sarr MG, Jensen MD, Vella A, Ahmed L, Belani K, Schone JL, Olofson AE, Bainbridge HA, Laqua PS, Korner J, Chuang LM. National Differences in Remission of Type 2 Diabetes Mellitus After Roux-en-Y Gastric Bypass Surgery-Subgroup Analysis of 2-Year Results of the Diabetes Surgery Study Comparing Taiwanese with Americans with Mild Obesity (BMI 30-35 kg/m2). Obes Surg. 2017 May;27(5):1189-1195. doi: 10.1007/s11695-016-2433-4.

    PMID: 27783367DERIVED

  • Ikramuddin S, Korner J, Lee WJ, Bantle JP, Thomas AJ, Connett JE, Leslie DB, Inabnet WB 3rd, Wang Q, Jeffery RW, Chong K, Chuang LM, Jensen MD, Vella A, Ahmed L, Belani K, Olofson AE, Bainbridge HA, Billington CJ. Durability of Addition of Roux-en-Y Gastric Bypass to Lifestyle Intervention and Medical Management in Achieving Primary Treatment Goals for Uncontrolled Type 2 Diabetes in Mild to Moderate Obesity: A Randomized Control Trial. Diabetes Care. 2016 Sep;39(9):1510-8. doi: 10.2337/dc15-2481. Epub 2016 Jun 16.

    PMID: 27311493DERIVED

  • Ikramuddin S, Billington CJ, Lee WJ, Bantle JP, Thomas AJ, Connett JE, Leslie DB, Inabnet WB 3rd, Jeffery RW, Chong K, Chuang LM, Sarr MG, Jensen MD, Vella A, Ahmed L, Belani K, Schone JL, Olofson AE, Bainbridge HA, Laqua PS, Wang Q, Korner J. Roux-en-Y gastric bypass for diabetes (the Diabetes Surgery Study): 2-year outcomes of a 5-year, randomised, controlled trial. Lancet Diabetes Endocrinol. 2015 Jun;3(6):413-422. doi: 10.1016/S2213-8587(15)00089-3. Epub 2015 May 12.

    PMID: 25979364DERIVED

  • Ikramuddin S, Korner J, Lee WJ, Connett JE, Inabnet WB, Billington CJ, Thomas AJ, Leslie DB, Chong K, Jeffery RW, Ahmed L, Vella A, Chuang LM, Bessler M, Sarr MG, Swain JM, Laqua P, Jensen MD, Bantle JP. Roux-en-Y gastric bypass vs intensive medical management for the control of type 2 diabetes, hypertension, and hyperlipidemia: the Diabetes Surgery Study randomized clinical trial. JAMA. 2013 Jun 5;309(21):2240-9. doi: 10.1001/jama.2013.5835.

    PMID: 23736733DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Sayeed Ikramuddin, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2008

First Posted

March 24, 2008

Study Start

February 1, 2008

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

November 29, 2017

Record last verified: 2017-11

Locations

US(3)TW(2)