NCT00765596

Brief Summary

The purpose of this study is to determine whether gastric division (via Roux-en-Y gastric bypass) with resultant fundic isolation will alter the pattern(s) of Ghrelin secretion in the early post-operative period following feeding in morbidly obese subjects.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 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

January 1, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2008

Completed
Last Updated

November 17, 2011

Status Verified

November 1, 2011

Enrollment Period

1.9 years

First QC Date

October 2, 2008

Last Update Submit

November 15, 2011

Conditions

ObesityInsulin Resistance

Keywords

ObesityInsulin resistanceGastric tubeGhrelin

Outcome Measures

Primary Outcomes (1)

  • Ghrelin

    pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op

Secondary Outcomes (2)

  • HOMA

    pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op

  • metabolic hormones

    pre-op, peri-op, immediately post-op, 2 days, 3 wks, 6wks, 6mos, 1 year post op

Study Arms (2)

1 RYGB

Subjects undergoing RYGB with gastric tube placement

2 Matched controls

Subjects matched by BMI, age, gender to RYGB group

Other: Liquid diet for 3 days

Interventions

Liquid diet for 3 daysOTHER

The control group were given a 3 -day liquid diet similar to the RYGB post-op diet

2 Matched controls

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects were morbidly obese, scheduled for RYGB with gastric tube placement. Controls were matched to subjects by BMI, age, gender.

You may qualify if:

  • Serum creatinine and liver function tests \< upper limits of normal
  • Stable body weights for the past three months
  • Women will have a negative pregnancy test
  • patients who are already scheduled for RYGB with gastrostomy tube placement

You may not qualify if:

  • Significant hepatic enzyme elevations (more than 100% of upper limits of normal)
  • Serum creatinine \> 1.5 mg/dl
  • history of ketoacidosis or current metabolic acidosis
  • current use of oral anticoagulants
  • Positive pregnancy test (beta-human chorionic gonadotrophin) for females
  • intercurrent infections
  • patients with prior gastric operations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (2)

  • Hansen EN, Tamboli RA, Isbell JM, Saliba J, Dunn JP, Marks-Shulman PA, Abumrad NN. Role of the foregut in the early improvement in glucose tolerance and insulin sensitivity following Roux-en-Y gastric bypass surgery. Am J Physiol Gastrointest Liver Physiol. 2011 May;300(5):G795-802. doi: 10.1152/ajpgi.00019.2011. Epub 2011 Mar 3.

    PMID: 21372167DERIVED

  • Isbell JM, Tamboli RA, Hansen EN, Saliba J, Dunn JP, Phillips SE, Marks-Shulman PA, Abumrad NN. The importance of caloric restriction in the early improvements in insulin sensitivity after Roux-en-Y gastric bypass surgery. Diabetes Care. 2010 Jul;33(7):1438-42. doi: 10.2337/dc09-2107. Epub 2010 Apr 5.

    PMID: 20368410DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

plasma, tissues

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

  • Naji N Abumrad, MD

    Department of Surgery, Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

  • Erik N Hansen, MD

    Departement of Surgery, Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman, Department of Surgery

Study Record Dates

First Submitted

October 2, 2008

First Posted

October 3, 2008

Study Start

January 1, 2005

Primary Completion

December 1, 2006

Last Updated

November 17, 2011

Record last verified: 2011-11

Locations

US(1)