NCT01044602

Brief Summary

Best medical management and gastric bypass surgery is a way to treat diabetes as part of regular medical care (standard of care). However, gastric bypass surgery is not a way to treat diabetes as part of regular medical care (standard of care).

Trial Health

87
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 obesity

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

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

January 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

April 21, 2015

Status Verified

April 1, 2015

Enrollment Period

4 years

First QC Date

January 7, 2010

Last Update Submit

April 20, 2015

Conditions

ObesityType 2 Diabetes Mellitus

Keywords

ObesityType 2 Diabetes MellitusRoux-en-Y Gastric Bypass Surgery

Outcome Measures

Primary Outcomes (2)

  • Resolution of type 2 diabetes mellitus, determined by oral glucose tolerance test.

    2 years

  • Resolution of obesity co-morbidities including hypertension, OSA, and hyperlipidemia

    2 years

Secondary Outcomes (3)

  • Improvement in glucose control

    2 years

  • Improvement in control of chronic co-morbidities

    2 years

  • Identify predictors of success with regard to improved co-morbidities and velocity of weight loss

    2 years

Study Arms (2)

Best Medical Management

ACTIVE COMPARATOR

Patients elect to treat obesity and type 2 diabetes mellitus through best medical management.

Other: Laboratory evaluations, sleep studyOther: Best Medical Management

Surgical Treatment

ACTIVE COMPARATOR

Patients with type 2 diabetes mellitus choice to treat obesity with Roux-en-Y gastric bypass.

Other: Laboratory evaluations, sleep studyProcedure: Roux-en-Y gastric bypass surgery

Interventions

Laboratory evaluations, sleep studyOTHER

Fasting plasma glucose, liver function tests, chem-7, HOMA-IR, HBA1C, lipid profile, indirect calorimetry.

Best Medical ManagementSurgical Treatment
Best Medical ManagementOTHER

Standard of care.

Best Medical Management
Roux-en-Y gastric bypass surgeryPROCEDURE

Surgical treatment.

Surgical Treatment

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 25 to 70
  • BMI 35 or greater
  • HbA1c\>6.5%
  • Stable weight
  • Stable medications

You may not qualify if:

  • Coagulopathy
  • Liver cirrhosis
  • C-peptide \<1 ng/ml (off insulin)
  • Diagnosis of severe eating disorder
  • Untreated endocrine disorder
  • Use of medication for weight loss in the past 6 months
  • Use of medication for weight loss in the last 6 months (with the exception of orlistat)
  • Pregnancy
  • Coagulopathy
  • Liver cirrhosis
  • Incurable, malignant, or debilitating disease
  • Severe eating disorder
  • Use of weight loss medication in the last 6 months, with the exception of orlistat
  • Untreated endocrine disorder
  • Pregnant
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Asem Ali, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 7, 2010

First Posted

January 8, 2010

Study Start

January 1, 2010

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

April 21, 2015

Record last verified: 2015-04

Locations

US(1)