NCT00936130

Brief Summary

The purpose of the study is to determine the effect of three weight loss surgeries compared to a low calorie diet with regard to energy expenditure, body composition, insulin sensitivity, and the response of gastrointestinal peptides to a standard meal. Baseline assessments will be conducted in all four groups and changes will be compared six and fifty-two weeks post-operatively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2010

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

First Submitted

Initial submission to the registry

July 1, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2009

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

December 4, 2015

Status Verified

December 1, 2015

Enrollment Period

4 years

First QC Date

July 1, 2009

Last Update Submit

December 3, 2015

Conditions

ObesityProtein-energy; ImbalanceInsulin SensitivityGastrointestinal Complication

Keywords

Roux-en-Y gastric bypass surgerySleeve gastrectomy (SGx) surgeryGastric banding (GBx) surgeryLow calorie diet program

Outcome Measures

Primary Outcomes (1)

  • Daily Energy Metabolism and insulin sensitivity

    Compare daily energy expenditure (accelerometry); body composition (EchoMRI, CT, MRS); insulin sensitivity (2-step hyperinsulinemic euglycemic clamp). Response of insulin, glucose, and gastrointestinal hormones. Changes in the stool microflora.

    Enrollment, Baseline, Week 6-8 and Week 48-56 post-surgery / LCD diet

Study Arms (2)

Lifestyle counseling

This group will be comprised of participants on a low calorie diet program.

Behavioral: Low Calorie Diet

Weight Loss Surgery

This group will be comprised of participants having weight loss surgery: Roux-en-Y gastric bypass, gastric banding, or sleeve gastrectomy.

Procedure: Laparoscopic Roux-en-Y gastric bypassProcedure: Laparoscopic gastric bandingProcedure: Laparoscopic sleeve gastrectomy

Interventions

Laparoscopic Roux-en-Y gastric bypassPROCEDURE

Laparoscopic Roux-en-Y gastric bypass surgery

Also known as: RYGB
Weight Loss Surgery
Laparoscopic gastric bandingPROCEDURE

Laparoscopic gastric banding surgery

Also known as: GBa
Weight Loss Surgery
Laparoscopic sleeve gastrectomyPROCEDURE

Laparoscopic sleeve gastrectomy surgery

Also known as: SGx
Weight Loss Surgery
Low Calorie DietBEHAVIORAL

Low Calorie Diet Program

Also known as: LCD
Lifestyle counseling

Eligibility Criteria

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

Medically qualified for obesity surgery by Drs LeBlanc or Hausmann

You may qualify if:

  • Men and women between ages of 18-65 years
  • Body mass index \>40 kg/m2 (BMI is calculated from your height and weight)
  • BMI \>35 kg/m2 with obesity associated diseases that should improve with weight loss (diabetes, hypertension, and sleep apnea)
  • Medically qualified for obesity surgery by Drs LeBlanc or Hausmann

You may not qualify if:

  • Women who are pregnant or unwilling to avoid pregnancy for 2 years post-operatively.
  • Diabetes diagnosed more than 5 years ago
  • Have had diabetes for more than 5 years
  • Have had surgery on your stomach or intestinal tract except to remove your appendix or gall bladder.
  • Have an active disease in your stomach or intestinal tract including inflammatory bowel disease.
  • Have thyroid disease that is not treated
  • Have any of the following psychiatric conditions that have not been treated to the point of complete remission: binge eating disorder, bulimia, current physical abuse, current sexual abuse, current substance abuse or dependence, mania or psychosis.
  • Have any of the following psychiatric conditions that have not been treated to the point of partial remission prior to your enrollment in this study: anxiety, depression, dysfunctional marriage/family, personality disorder or post-traumatic stress disorder.
  • Have a failure of one of your major organ systems. For example, liver failure, kidney failure, severe blood vessel blockage, or are not mentally able to understand the study and give your consent.
  • Have a heart pacemaker or defibrillator, or any type of non-removable, metal containing objects in your body, as well as those with tattoos containing metallic dyes.
  • Can not drink milk or products containing milk.
  • Taking medications that alter your weight or metabolic rate. For example, antipsychotic drugs, beta adrenergic drugs (beta blockers), as well as anorectic drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedial Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (3)

  • Broskey NT, Obanda DN, Burton JH, Cefalu WT, Ravussin E. Skeletal muscle ceramides and daily fat oxidation in obesity and diabetes. Metabolism. 2018 May;82:118-123. doi: 10.1016/j.metabol.2017.12.012. Epub 2018 Jan 4.

    PMID: 29307520DERIVED

  • Tam CS, Redman LM, Greenway F, LeBlanc KA, Haussmann MG, Ravussin E. Energy Metabolic Adaptation and Cardiometabolic Improvements One Year After Gastric Bypass, Sleeve Gastrectomy, and Gastric Band. J Clin Endocrinol Metab. 2016 Oct;101(10):3755-3764. doi: 10.1210/jc.2016-1814. Epub 2016 Aug 4.

    PMID: 27490919DERIVED

  • Lam YY, Redman LM, Smith SR, Bray GA, Greenway FL, Johannsen D, Ravussin E. Determinants of sedentary 24-h energy expenditure: equations for energy prescription and adjustment in a respiratory chamber. Am J Clin Nutr. 2014 Apr;99(4):834-42. doi: 10.3945/ajcn.113.079566. Epub 2014 Feb 5.

    PMID: 24500151DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood draw, urine, stool, fat and muscle biopsies.

MeSH Terms

Conditions

ObesityInsulin Resistance

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Eric Ravussin, Ph.D.

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
p

Study Record Dates

First Submitted

July 1, 2009

First Posted

July 9, 2009

Study Start

September 1, 2010

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

December 4, 2015

Record last verified: 2015-12

Locations

US(1)