Assessing Trauma-related Links Between Affective and Metabolic Systems

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21-75
SponsorVA Office of Research and Development

About this trial

KEY INFORMATION: The purpose of this study is to understand how insulin resistance (how your body processes sugar) and PTSD might be related. The goal is to improve the health of Veterans in three ways:

1. Understanding health risks: The investigators want to learn why Veterans with post-traumatic stress disorder (PTSD) are more likely to develop medical problems related to insulin resistance, such as diabetes. 2. Testing effects of a medication: The investigators are testing whether prazosin, a medication that studies have shown may address some PTSD symptoms, can also improve how the body responds to insulin. If it does, this could point to a specific biological pathway that could be targeted for development of new treatments to prevent insulin resistance and diabetes in Veterans with PTSD. 3. Links to depression. The investigators will also look at whether insulin sensitivity affects depression symptoms in people with PTSD. This may inform future research into treatments for PTSD.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Veteran of the US military

Diagnosis of post-traumatic stress disorder (PTSD) defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptom count on Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

Disqualifiers

Any form of diabetes as defined by the American Diabetes Association. Exceptions may be made for participants with previously undiagnosed, early, asymptomatic Type 2 Diabetes Mellitus (T2DM) who meet American Diabetes Association criteria for diabetes during study screening who wish to be included

Diagnosis of DSM-5-defined bipolar I, schizophrenia spectrum or other psychotic disorders (by MINI)

Diagnosis of dementia or related progressive neurocognitive disorder, based on clinical records

Diagnosis of moderate or severe substance use disorder (except for caffeine and nicotine) during the preceding 3 months

Trial design

Design model

Single group

Treatments tested in this trial

  • prazosin

    Drug

    All participants will receive prazosin for 12 weeks

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: PrazosinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Aim 1 primary outcome

Correlation between baseline noradrenergic signaling (standing systolic blood pressure) and insulin sensitivity (OGIS)

Time frame
5 years
2

Aim 2 primary outcome

Change in insulin sensitivity (OGIS) in response to prazosin

Time frame
5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: