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NCT04437485 · ClinicalTrials.gov registry record · Phase 2
eIMPACT-DM Pilot Trial: Depression Treatment to Reduce Diabetes Risk
A Phase 2 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT04437485: Completed Phase 2 study, sponsored by Indiana University.
NCT04437485 is a Phase 2 study that has completed, run by Indiana University. The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04437485, a Phase 2 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study Summary
This pilot randomized controlled trial seeks: (1) to determine the preliminary efficacy of our modernized collaborative care intervention for depression in improving the diabetes risk markers of hemoglobin A1c and insulin resistance and (2) to explore whether somatic depressive symptoms - i.e., hyperphagia (increased appetite/weight) and/or hypersomnia (increased sleep) - moderate the effect of the eIMPACT-DM intervention on diabetes risk markers.
Primary Outcome
Fasting blood samples were collected, and whole blood and plasma aliquots were frozen. Hemoglobin A1c will be measured by a standard method. A1c is the primary outcome because: (1) it is the gold standard measure of glycemia and a common surrogate endpoint, (2) it strongly predicts future diabetes, (3) interventions decreasing A1c improve clinical diabetes endpoints, and (4) diabetes prevention interventions targeting glycemic control result in lower rates of progression from prediabetes to type
Interventions
- OTHER Active Control
- BEHAVIORAL Problem Solving Treatment in Primary Care (PST-PC)
- DRUG Antidepressant Medications
- BEHAVIORAL Good Days Ahead (GDA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2020-10-14 |
| Est. Completion | 2022-08-29 |
| Phase | Phase 2 |
What the finished NCT04437485 record still lists
NCT04437485 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 4 interventions - of which Active Control is the first listed.
NCT04437485 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04437485 about?
NCT04437485 is a clinical study titled "eIMPACT-DM Pilot Trial: Depression Treatment to Reduce Diabetes Risk". This pilot randomized controlled trial seeks: (1) to determine the preliminary efficacy of our modernized collaborative care intervention for depression in improving the diabetes risk markers of hemoglobin A1c and insulin resistance and (2) to explore whether somatic depressive symptoms - i.e., hype...
What is the current status of trial NCT04437485?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2020-10-14. Estimated completion is 2022-08-29.
What interventions are being tested in trial NCT04437485?
The interventions under investigation include: Active Control (OTHER), Problem Solving Treatment in Primary Care (PST-PC) (BEHAVIORAL), Antidepressant Medications (DRUG), Good Days Ahead (GDA) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04437485?
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 NCT04437485's enrollment target sits among peer trials
46 1286th of 2000 higher than 705 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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