NCT00884494

Brief Summary

Ghrelin, a hormone produced in the stomach that stimulates hunger and food intake, declines immediately after weight loss surgery. Some studies suggest that ghrelin may worsen an individual's ability to respond to insulin. The purpose of this study is to determine if the decline in ghrelin levels after weight loss surgery contributes to the improvement of insulin sensitivity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_1 obesity

Timeline
Completed

Started Aug 2011

Longer than P75 for phase_1 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

First Submitted

Initial submission to the registry

April 16, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 20, 2009

Completed
2.3 years until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

January 20, 2017

Status Verified

January 1, 2017

Enrollment Period

2.8 years

First QC Date

April 16, 2009

Last Update Submit

January 18, 2017

Conditions

ObesityInsulin ResistanceNormal Weight,Healthy Controls

Keywords

ObesityInsulin resistanceGhrelin

Outcome Measures

Primary Outcomes (1)

  • Evaluate the effect of ghrelin on insulin resistance in obese subject, as well as subjects in the immediate post-RYGB period.

    1 year

Study Arms (2)

Roux-en-Y gastric bypass

EXPERIMENTAL
Drug: Ghrelin infusion to assess effects on insulin sensitivity

Lean

EXPERIMENTAL
Drug: Ghrelin infusion to assess effects on insulin sensitivity

Interventions

Ghrelin infusion to assess effects on insulin sensitivityDRUG
LeanRoux-en-Y gastric bypass

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65
  • BMI \> 35 kg/m2
  • Scheduled for bariatric surgery at Vanderbilt University Medical Center
  • Age 18-65
  • BMI \< 30kg/m2

You may not qualify if:

  • Prior bariatric surgery
  • Serum creatinine \> 1.5 mg/dl
  • Hepatic enzyme elevations \> 2x upper limits of normal
  • Current use of warfarin or clopidogrel
  • Intercurrent infections
  • Females with positive pregnancy test
  • Abnormal ECG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • Garcia AE, Kasim N, Tamboli RA, Gonzalez RS, Antoun J, Eckert EA, Marks-Shulman PA, Dunn J, Wattacheril J, Wallen T, Abumrad NN, Flynn CR. Lipoprotein Profiles in Class III Obese Caucasian and African American Women with Nonalcoholic Fatty Liver Disease. PLoS One. 2015 Nov 23;10(11):e0142676. doi: 10.1371/journal.pone.0142676. eCollection 2015.

    PMID: 26599819DERIVED

MeSH Terms

Conditions

ObesityInsulin Resistance

Condition Hierarchy (Ancestors)

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

Study Officials

  • Robyn Tamboli, PhD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

  • Naji Abumrad, MD

    Vanderbilt University Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

April 16, 2009

First Posted

April 20, 2009

Study Start

August 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

January 20, 2017

Record last verified: 2017-01

Locations

US(1)