NCT01278823

Brief Summary

The purpose of this study is to determine the effects of bariatric surgery on blood sugar control and underlying mechanisms that contribute to type 2 diabetes in men and women with a BMI between 27 and 42. Sixty subjects will be randomized to either undergo the roux-en-y gastric bypass operation or intensive medical, dietary and exercise management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2011

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, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2017

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

6.1 years

First QC Date

January 17, 2011

Last Update Submit

July 9, 2019

Conditions

ObesityType 2 Diabetes

Keywords

obesitytype 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • Test the effect of gastric bypass surgery on glycemic control in obese type 2 DM patients

    The working hypothesis for this aim is that significantly more obese T2DM patients who undergo RYGB surgery will achieve glycemic control based on a primary endpoint of an HbA1c ≤ 6.5% at 12 months, than patients managed by intensive medical therapy.

    12 months

Secondary Outcomes (1)

  • Determine the effects of gastric bypass surgery on pancreatic beta cell function and incretin hormone secretion in obese type 2 dm patients

    12 months

Study Arms (2)

surgery

EXPERIMENTAL

Surgery: laparoscopic roux en y gastric bypass operation

Procedure: laparoscopic roux en y gastric bypass operation

Medical treatment

ACTIVE COMPARATOR

Medical Treatment: Comprehensive medical management of diabetes including medications, diet intervention, lifestyle modification, exercise regimen

Other: medical management

Interventions

laparoscopic roux en y gastric bypass operationPROCEDURE

roux en y gastric bypass operation

Also known as: bariatric surgery
surgery
medical managementOTHER

latest type 2 diabetes medications, lifestyle/behavior modification and dietary regimen

Also known as: meal replacement, exercise, group support
Medical treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • candidate for general surgery
  • to 60 years old
  • BMI 27-43
  • type 2 diabetes
  • willing to participate in either study arm
  • understand and comply with requirements of each arm
  • not pregnant
  • willing to use reliable birth control for duration of study

You may not qualify if:

  • prior bariatric surgery of any type
  • prior complex abdominal surgery
  • abdominal, thoracic, pelvic, obstetrical surgery within last 6 months
  • significant cardiovascular disease
  • kidney disease with a creatinine greater than or equal to 1.8 mg/dl
  • chronic liver disease except for NAFLD/NASH
  • celiac, malabsorptive, inflammatory bowel disorders
  • psychiatric disorders requiring 3 or more medications
  • pregnancy
  • cancer except squamous or basal cell skin cancer or cancer in remission
  • anticoagulation therapy that can't be stopped for surgery
  • clotting disorders
  • severe pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Bariatric and Metabolic Institute, Department of Pathobiology

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

  • Kirwan JP, Axelrod CL, Kullman EL, Malin SK, Dantas WS, Pergola K, Del Rincon JP, Brethauer SA, Kashyap SR, Schauer PR. Foregut Exclusion Enhances Incretin and Insulin Secretion After Roux-en-Y Gastric Bypass in Adults With Type 2 Diabetes. J Clin Endocrinol Metab. 2021 Sep 27;106(10):e4192-e4201. doi: 10.1210/clinem/dgab255.

    PMID: 33870426DERIVED

Related Links

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2

Interventions

Bariatric SurgeryPractice Management, MedicalExerciseSelf-Help Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, OperativePractice ManagementProfessional PracticeOrganization and AdministrationHealth Services AdministrationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaOrganizationsHealth Care Economics and Organizations

Study Officials

  • John Kirwan, PhD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 17, 2011

First Posted

January 19, 2011

Study Start

January 1, 2011

Primary Completion

February 15, 2017

Study Completion

February 15, 2017

Last Updated

July 11, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)