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