NCT01474785

Brief Summary

The purpose of this study is to determine if interruption in gastric-adipose tissue axis signaling contributes to early improvements in oxidative stress, insulin sensitivity, and inflammation, and to determine if interruption of the stomach in RYGB results in reduction of plasma acylated ghrelin (AG) and in an altered acylated ghrelin:unacylated ghrelin (AG:UAG) ratio which may contribute to decreased oxidative stress and improved insulin sensitivity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P50-P75 for phase_1 obesity

Timeline
Completed

Started Jan 2012

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

November 15, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 18, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

May 21, 2018

Status Verified

January 1, 2018

Enrollment Period

3.5 years

First QC Date

November 15, 2011

Last Update Submit

May 18, 2018

Conditions

Obesity

Keywords

ObesityBariatric surgeryNashville, Tennessee

Outcome Measures

Primary Outcomes (1)

  • change in glucose disposal rate

    Glucose disposal rate is a sensitive laboratory procedure for determining how your body uses sugar (called insulin sensitivity).

    baseline and 1 week

Study Arms (3)

RYGB

EXPERIMENTAL

Roux-en-Y gastric bypass surgery (RYGB) subjects to undergo hyperinsulinemic-euglycemic clamp with human ghrelin infusion pre-operatively and post-operatively.

Drug: human ghrelinProcedure: Hyperinsulinemic/Euglycemic Clamp

VSG

EXPERIMENTAL

Vertical sleeve gastrectomy (VSG) subjects to undergo hyperinsulinemic-euglycemic clamp pre-operatively and post-operatively.

Procedure: Hyperinsulinemic/Euglycemic Clamp

Low Calorie Diet

EXPERIMENTAL

Subjects will receive very low calorie diet prescribed for RYGB patients and undergo hyperinsulinemic-euglycemic before and after diet.

Other: very low calorie dietProcedure: Hyperinsulinemic/Euglycemic Clamp

Interventions

human ghrelinDRUG

0.5-1 pmol/kg.min of human ghrelin administered by IV two times

RYGB
very low calorie dietOTHER

standard very low calorie diet that is prescribed for all RYGB patients after their operation

Low Calorie Diet
Hyperinsulinemic/Euglycemic ClampPROCEDURE

Insulin and glucose infusions to measure glucose kinetics.

Low Calorie DietRYGBVSG

Eligibility Criteria

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

You may qualify if:

  • Age 18-65 years
  • BMI ≥ 35 kg/m\^2
  • Scheduled for bariatric surgery
  • Considering bariatric surgery
  • Waiting for insurance approval for bariatric surgery
  • Currently not considering bariatric surgery, but otherwise eligible
  • Enrollment in medical weight loss program

You may not qualify if:

  • Smoking \>7 cigarettes per day
  • Precious malabsorptive or restrictive intestinal surgery
  • Pregnant or breastfeeding
  • Recent history of neoplasia (5\<years ago)
  • Malabsorptive syndromes
  • Inflammatory intestinal disease
  • Established organ disfunction
  • Allergy to acetaminophen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 34232, United States

Location

Related Publications (1)

  • Flynn CR, Tamboli RA, Antoun J, Sidani RM, Williams B, Spann MD, English WJ, Welch EB, Sundaresan S, Abumrad NN. Caloric Restriction and Weight Loss Are Primary Factors in the Early Tissue-Specific Metabolic Changes After Bariatric Surgery. Diabetes Care. 2022 Aug 1;45(8):1914-1916. doi: 10.2337/dc22-0069.

    PMID: 35724307DERIVED

MeSH Terms

Conditions

Obesity

Interventions

GhrelinGlucose Clamp Technique

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsBlood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Naji Abumrad, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery, Chairman Department of Surgery

Study Record Dates

First Submitted

November 15, 2011

First Posted

November 18, 2011

Study Start

January 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

May 21, 2018

Record last verified: 2018-01

Locations

US(1)