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NCT01607450 · ClinicalTrials.gov registry record · Phase 2
Modulation of Human Myocardial Metabolism by GLP-1 Dose Response
A Phase 2 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
NCT01607450: Completed Phase 2 study, sponsored by Indiana University.
NCT01607450 is a Phase 2 study that has completed, run by Indiana University. The registered enrollment target is 33 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01607450, a Phase 2 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
Study Summary
The objective of this proposal is to provide quantitative dose-response data for effects of GLP-1 on myocardial glucose uptake in healthy control subjects and obese type 2 diabetic subjects, in support of the design of later studies evaluating therapeutic applications of GLP-1 to heart disease. Aim 1: To measure the effects of GLP-1 infusion on myocardial fuel selection in lean healthy humans under fasting (fatty acid-dominant) conditions. Four groups of 10 lean healthy subjects will be studied during infusions of 0 (saline control), 0.5, 1.5, and 4.0 pmol/kg/min GLP-1 (one study per subject). Cardiac metabolism will be measured using PET, using a dual-tracer approach which allows measurement of myocardial glucose uptake (the primary endpoint) along with total oxidation rate and myocardial perfusion (secondary endpoints). In concert with measures of circulating metabolites and regulatory hormones, the investigators will produce the most comprehensive assessment of actions of GLP-1 on myocardial metabolism in humans to date. Effects of each dose will be compared to the saline control, plus the investigators will combine all data and use nonlinear curve-fitting to derive sensitivity (ED50) and maximal responses for GLP-1 effects on myocardial glucose uptake. Aim 2: To measure the effects of GLP-1 infusion on myocardial fuel selection in obese type 2 diabetic humans under fasting (fatty acid-dominant) conditions Four groups of 10 obese type 2 diabetic subjects will be studied during infusions of 0, 0.5, 1.5, and 4.0 pmol/kg/min GLP-1 as under Aim 1. Analyses will be parallel to those described under Aim 1. Results from Aims 1 and 2 will be combined to allow direct comparison of the dose-response between nondiabetic control and type 2 diabetic subjects. No literature has been published to inform dose selection in the design of clinical trials of GLP-1 for modulation of heart fuel selection. With our expertise and experience in PET measurement of heart metabolism in d
Primary Outcome
Myocardial glucose uptake measured using 18FDG PET, quantified using a 3-compartment model with a lumped constant of 1.0.
Interventions
- DRUG Saline
- DRUG GLP-1 Low Dose
- DRUG GLP-1 Mid-Range Dose
- DRUG GLP-1 High Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
What the finished NCT01607450 record still lists
NCT01607450 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 4 interventions - of which Saline is the first listed.
NCT01607450 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01607450 about?
NCT01607450 is a clinical study titled "Modulation of Human Myocardial Metabolism by GLP-1 Dose Response". The objective of this proposal is to provide quantitative dose-response data for effects of GLP-1 on myocardial glucose uptake in healthy control subjects and obese type 2 diabetic subjects, in support of the design of later studies evaluating therapeutic applications of GLP-1 to heart disease. Aim...
What is the current status of trial NCT01607450?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2010-05. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01607450?
The interventions under investigation include: Saline (DRUG), GLP-1 Low Dose (DRUG), GLP-1 Mid-Range Dose (DRUG), GLP-1 High Dose (DRUG).
Who is sponsoring clinical trial NCT01607450?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01607450's enrollment target sits among peer trials
33 1553rd of 2000 higher than 438 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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