NCT00627484

Brief Summary

This study is designed to compare the changes in insulin sensitivity as well as gastrointestinal hormone levels in diabetic and non-diabetic obese individuals who are undergoing weight loss procedures. The main hypothesis of this study is that weight loss induced by gastric bypass will induce a greater improvement in insulin sensitivity compared with gastric banding or low calorie diet. Subjects will be studied before and after weight loss. Studies consist of intravenous glucose tolerance test, body composition analysis, meal test, and energy expenditure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
119

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2005

Longer than P75 for all trials

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

March 1, 2005

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2008

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2018

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

13.3 years

First QC Date

February 28, 2008

Last Update Submit

September 18, 2019

Conditions

ObesityType 2 Diabetes MellitusInsulin Resistance

Keywords

Insulin resistanceInsulin sensitivitybariatric surgerydiabetescalorie restrictionbody composition

Outcome Measures

Primary Outcomes (1)

  • Change in Insulin Sensitivity

    Measured by frequently sampled intravenous glucose tolerance test (FSIVGTT)

    2-8 weeks

Secondary Outcomes (2)

  • Change in Body Composition

    2-8 weeks

  • Change in Resting Energy Expenditure

    Up to 4 hrs post-meal

Study Arms (5)

Group 1: GBP non-diabetic

Non-diabetic subjects scheduled to receive gastric bypass

Procedure: Gastric bypass

Group 2: BND non-diabetic

Non-diabetic subjects scheduled to receive gastric banding

Procedure: Gastric banding

Group 3: GBP diabetic

Diabetic subjects scheduled to receive gastric bypass

Procedure: Gastric bypass

Group 4: VLCD diabetic

Diabetic subjects scheduled to receive very low calorie diet

Behavioral: Very low calorie diet

Group 5: SG diabetic

Diabetic subjects scheduled to receive sleeve gastrectomy

Procedure: Sleeve gastrectomy

Interventions

Gastric bypassPROCEDURE

NOTE: the surgery is not paid for by the study

Also known as: GBP
Group 1: GBP non-diabeticGroup 3: GBP diabetic
Gastric bandingPROCEDURE

NOTE: the surgery is not paid for by the study

Also known as: BND
Group 2: BND non-diabetic
Sleeve gastrectomyPROCEDURE

NOTE: the surgery is not paid for by the study

Also known as: SG
Group 5: SG diabetic
Very low calorie dietBEHAVIORAL

Weight loss with calorie restricted liquid diet. Subject will be asked to stay in our in-patient research unit for 2-3 weeks and consume only those foods supplied by our bionutrition unit. Expected weight loss should be between 7-10% of body weight. Subjects will receive the diet at no cost and will be compensated for their time.

Also known as: VLCD
Group 4: VLCD diabetic

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects will be recruited by physician referral and from outpatient obesity, bariatric surgical clinics and endocrinology clinics at Columbia University Medical Center as well as from the Medical Center Community and metropolitan area via IRB-approved flyers and internet postings. Subjects will also be recruited from the following website: www.craigslist.com using the same posting format of the IRB-approved flyers.

You may qualify if:

  • Non-diabetic obese (BMI \> 30) adult men and women between the ages of 18 and 75 scheduled to undergo
  • gastric bypass (GBP)
  • gastric banding (BND)
  • Type 2 diabetes (HbA1c 6-12%) adult men and women between the ages of 18 and 75 scheduled to undergo gastric bypass.
  • Type 2 diabetes (HbA1c 6-12%) adult men and women between the ages of 18 and 65 for weight reduction with a very low caloric diet (VLCD).
  • Type 2 diabetes mellitus scheduled to undergo sleeve gastrectomy (SG).

You may not qualify if:

  • Pregnancy.
  • Age \> 75 for surgery groups; Age \> 65 for VLCD group.
  • Treatment with glucocorticoids, anti-depressants, anti-psychotics, neuroleptics, weight loss medications, experimental medication.
  • Greater than a 5% change in total body weight in the 90 days prior to the study.
  • History of untreated gallstones; hepatic or renal insufficiency, abnormal thyroid stimulating hormone (TSH).
  • Use of thiazolidinedione therapy.
  • HbA1c \> 12%.
  • Use of dipeptidyl peptidase IV (DPP-IV) inhibitor or glucagon-like peptide 1 receptor (GLP-1R) agonist for greater than 12 months within 3 months of the study.
  • Fasting triglycerides \> 400.
  • Significant cardiovascular, neurologic, renal, gastrointestinal, or hematologic disease.
  • Inability to comply with or understand the study protocol as ascertained by the PI.
  • We will not exclude individuals with body weight \> 145 kg, but we do recognize that such individuals are above the table weight limitations of the dual-energy x-ray absorptiometry (DEXA) scan and body composition data will be unavailable for those individuals.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

  • Jackness C, Karmally W, Febres G, Conwell IM, Ahmed L, Bessler M, McMahon DJ, Korner J. Very low-calorie diet mimics the early beneficial effect of Roux-en-Y gastric bypass on insulin sensitivity and beta-cell Function in type 2 diabetic patients. Diabetes. 2013 Sep;62(9):3027-32. doi: 10.2337/db12-1762. Epub 2013 Apr 22.

    PMID: 23610060DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

The researchers may want to retain your blood and/or tissue sample(s) so that additional research studies can be done now or in the future.

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Insulin ResistanceDiabetes Mellitus

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Judith Korner, MD,PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

February 28, 2008

First Posted

March 3, 2008

Study Start

March 1, 2005

Primary Completion

June 17, 2018

Study Completion

June 17, 2018

Last Updated

September 19, 2019

Record last verified: 2019-09

Locations

US(1)