NCT01729299

Brief Summary

To determine the role of nutrient status on ghrelin regulation of insulin secretion. We hypothesize that ghrelin and glucagon-like peptide-1 (GLP-1)(both are hormones made in the gut,) have differential effects on β-cell function in the fed state. We will compare insulin secretion and glucose turnover during meal ingestion using a dual glucose tracer and mixed meal protocol in subjects receiving ghrelin or saline. We will also determine the role of ghrelin-stimulated GLP-1 levels in this process using the GLP-1 receptor (GLP-1R) antagonist Exendin(9-39) (Ex-9).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

2 active sites

Status
unknown

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 13, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 4, 2013

Status Verified

April 1, 2013

Enrollment Period

1 year

First QC Date

November 13, 2012

Last Update Submit

April 2, 2013

Conditions

Diabetes

Keywords

ghrelinglucose controlGLP-1Exendin (9-39)insulin

Outcome Measures

Primary Outcomes (1)

  • post-prandial insulin secretion

    Postprandial insulin secretion (ISR-meal) will be derived from plasma C-peptide concentrations during MTT using deconvolution with population estimates of C-peptide clearance.

    1 year

Secondary Outcomes (11)

  • endogenous GLP-1 contribution to postprandial insulin secretion

    1 year

  • β-cell response to glucose

    1 year

  • insulin sensitivity

    1 year

  • fasting EGP

    1 year

  • glucose appearance

    1 year

  • +6 more secondary outcomes

Study Arms (4)

saline

PLACEBO COMPARATOR

Saline: 0.9% saline solution

Drug: saline

ghrelin and exendin (9-39)

EXPERIMENTAL

Ghrelin+Ex-9: Combination of ghrelin and Ex-9,

Drug: Exendin (9-39)Drug: acyl ghrelin

Exendin (9-39)

EXPERIMENTAL

Exendin (9-39) (25 µg/kg) bolus over 1 min followed by a continuous infusion of 2.5 µg/kg/min

Drug: Exendin (9-39)

ghrelin

EXPERIMENTAL

synthetic human Acyl Ghrelin (0.28 μg/kg) bolus over 1 min followed by 2 μg/kg/h continuous infusion,

Drug: acyl ghrelin

Interventions

Exendin (9-39)DRUG
Exendin (9-39)ghrelin and exendin (9-39)
acyl ghrelinDRUG
ghrelinghrelin and exendin (9-39)
salineDRUG
saline

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women
  • Ages between 18 and 45 years
  • BMI between 18 and 29 kg/m2

You may not qualify if:

  • History or clinical evidence of impaired fasting glucose or diabetes mellitus, myocardial infarction within the past year, history or symptoms of congestive heart failure, uncontrolled hypertension, history or active liver or renal disease (AST or ALT \>2x upper limits of normal, calculated glomerular filtration rate \[GFR\] \<60).
  • History of pituitary or adrenal disorders or neuroendocrine tumor.
  • Anemia defined as hematocrit \<33%.
  • Use of medications that alter glucose metabolism
  • Pregnancy or lactation.
  • Abnormal Electrocardiogram (ECG): evidence of ischemia or arrhythmia.
  • Women who have a positive pregnancy test at any time during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

Cincinnati Children's Hospital and Medical Center

Cincinnati, Ohio, United States

RECRUITING

Related Publications (1)

  • Page LC, Gastaldelli A, Gray SM, D'Alessio DA, Tong J. Interaction of GLP-1 and Ghrelin on Glucose Tolerance in Healthy Humans. Diabetes. 2018 Oct;67(10):1976-1985. doi: 10.2337/db18-0451. Epub 2018 Jul 31.

    PMID: 30065032DERIVED

MeSH Terms

Conditions

Diabetes MellitusInsulin Resistance

Interventions

exendin (9-39)acyl-ghrelinSodium Chloride

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Jenny Tong, MD, MPH

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Tong, MD, MPH

CONTACT

513-558-4446jenny.tong@uc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 13, 2012

First Posted

November 20, 2012

Study Start

April 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 4, 2013

Record last verified: 2013-04

Locations

US(2)