Insulin resistance in brain reward pathways - the missing link between diabetes and depressio

Not Applicable

Recruiting

• Conditions: F32; R73; Depressive episode; Elevated blood glucose level

• Registration Number: DRKS00024801
• Lead Sponsor: eurometabolic circuitry Lab Department for Psychiatry, Psychosomatics and Psychotherapy Goethe University Frankfurt

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Inclusion criteria for controls:
• Age:18-65 years
• Ability to give consent

Inclusion criteria for diabetic patients:
• Age:18-65 years
• Presence of a prediabetic or diabetic condition according to the American Diabetes Association (American Diabetes, 2020):
• Ability to give informed consent
- only Metformin as medication allowed

Inclusion criteria for depressive patients:
• Age:18-65 years
• Presence of a depressive Episode, both first episode or an an episode in the context of a know recurrent depressive disorder with or without psychotic symptoms (according to ICD 10: F32.0, F32.1, F32.2, F32.3, F33.2, F33.3).
• Ability to give consent

Exclusion Criteria

Exclusion criteria for controls:
• History of
- Diabetes mellitus or prediabetic condition
- Psychiatric diseases
- neurological, autoimmune, rheumatological, neoplastic, dermatological or metabolic disorders
- acute infection
• Pregnancy and lactation
• Regular medication with insulin, insulin-mimetika, antitiabetic drugs
• Weight loss > 5 % of body weight within the last three months

Exclusion criteria for patients:
• History of
- psychiatric disease: dementia, bipolar disorder, schizophrenic psychosis, substance abuse disorder
- neurological, autoimmune, rheumatological, neoplastic, dermatological or other metabolic disorders than diabetes mellitus or prediabetes
- skin disseases
- acute infection
• Medication with insulin/insulin-mimetika or glucocorticoids
• Clearly organic or substance-induced cause of depression
• Pregnancy and nursing
• Weight loss > 5 % of body weight within the last three months

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in fMRI brain activity during the performance of the reward task and the emotional stimulus processing task, following intranasal insulin administration, is investigated in depressed patients and patients with insulin resistance, compared to the activity after intranasal placebo administration, in comparison to the control group.

Secondary Outcome Measures

Name	Time	Method
The alteration in reward learning and stress perception is investigated in depressed patients and patients with insulin resistance, compared to control subjects.