Overview

eIMPACT-DM Pilot Trial: Depression Treatment to Reduce Diabetes Risk

Status:
Recruiting
Trial end date:
2022-01-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Indiana University
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Treatments:
Antidepressive Agents
Bupropion
Norepinephrine
Serotonin
Serotonin Uptake Inhibitors
Criteria
Inclusion Criteria:

- Current primary care patient in Eskenazi Health

- Age ≥18 years

- Depressive disorder at screening

- Prediabetes at screening

Exclusion Criteria:

- History of type 1 or type 2 diabetes

- Major inflammatory conditions: HIV/AIDS, chronic kidney disease, systemic inflammatory
disease (e.g., rheumatoid arthritis, lupus, Crohn's disease, and ulcerative colitis),
or active cancer/current cancer treatment

- Current pregnancy

- Severe cognitive impairment

- Acute risk of suicide

- History of bipolar disorder or psychosis or current use of an atypical antipsychotic
medication:

- Participation in our prior eIMPACT Trial