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Hormone Therapy

ghrelin for Diabetes

N/A
Waitlist Available
Led By Jenny Tong, MD, MPH
Research Sponsored by David Dalessio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study 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).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
post-prandial insulin secretion
Secondary outcome measures
EGP during MTT
area under the curve
endogenous GLP-1 contribution to postprandial insulin secretion
+8 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: ghrelin and exendin (9-39)Experimental Treatment2 Interventions
Ghrelin+Ex-9: Combination of ghrelin and Ex-9,
Group II: ghrelinExperimental Treatment1 Intervention
synthetic human Acyl Ghrelin (0.28 μg/kg) bolus over 1 min followed by 2 μg/kg/h continuous infusion,
Group III: Exendin (9-39)Experimental Treatment1 Intervention
Exendin (9-39) (25 µg/kg) bolus over 1 min followed by a continuous infusion of 2.5 µg/kg/min
Group IV: salinePlacebo Group1 Intervention
Saline: 0.9% saline solution
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avexitide
Not yet FDA approved

Find a Location

Who is running the clinical trial?

David DalessioLead Sponsor
2 Previous Clinical Trials
72 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,705 Previous Clinical Trials
7,507,191 Total Patients Enrolled
24 Trials studying Diabetes
64,147 Patients Enrolled for Diabetes
Jenny Tong, MD, MPHPrincipal InvestigatorUniversity of Cincinnati
1 Previous Clinical Trials

Frequently Asked Questions

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Recent research and studies
clinicaltrials.govStudy
Ghrelin Effect on Beta Cell Function in Health and Disease
David Dalessio 2013. "Ghrelin Effect on Beta Cell Function in Health and Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01729299.
All > Health
~2 spots leftby May 2025
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