Steroid and Behaviour Changes Under Metformin

Insel Gruppe AG, University Hospital Bern

Status: Unknown

Conditions: Autistic Disorder

Treatments: Drug: Metformin

Study type: Observational

Funder types: Other

Identifiers

NCT04930471

Steroid Changes Metformin

Details and patient eligibility

About

Background

Based on various suggestions, social behavior is mediated by a change in steroid hormones. These have diverse effects on the (neuro-)development during critical stages, whereby especially androgen and insulin metabolism seem to play a key role. Various lines of evidence indicate that metformin could influence and improve the symptoms of social withdrawal. Therefore, the investigators will analyze urinary samples of patients before and after treatment with metformin to elucidate the changes in steroid hormone profiles and measure changes in social behavior to examine a potential correlation.

Material & Methods

Steroid hormone analysis including the most prominent androgen, estrogen, progesterone, aldosterone, corticosterone, cortisone and cortisol metabolites analyzed with gas chromatography mass spectrometry and a questionnaire (Autism-Spectrum Quotient) will be performed prior to and after 12-weeks metformin treatment.

Discussion

It is likely, that due to different pathophysiological mechanisms such as an effect on respiratory chain in mitochondria or via AMP activated protein kinase a general reduction of total androgens will be detected prior versus post metformin treatment. The encompassing measurement of steroid hormones will allow to detect influences on different metabolites and in consequence enzyme activities. The potential changes prior versus post shall give hints concerning the involvement of specific cascades involved, with potential pharmacological targets for future research.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with type 2 diabetes mellitus and an indication for metformin according to the American Diabetes Association (American Diabetes Association, 2021a) starting a new metformin treatment. The main marker will be fasting plasma glucose levels of 7.0mmol/L and/or HbA1c 6.5% (American Diabetes Association, 2021a).
• Written informed consent.

Exclusion criteria

• Patients under 18 years of age.
• Clinically significant concomitant disease (e.g. advanced renal failure, hepatic dysfunction, neoplasia).
• Significant musculoskeletal disease.
• Active infection during sample collection.
• Immunosuppressive medical therapy.
• Hormonal/steroid treatment.
• Pregnancy.
• Psychiatric disease and known social behavior altering medication (e.g. antipsychotic medication).
• Known or suspected malcompliance, drug or alcohol abuse.
• Inability to follow the procedures of the study, e.g. due to insufficient language skills, severe dementia.
• Life-expectancy < 6 months.
• Poor tolerability to metformin treatment with following treatment discontinuation within duration of follow up.

Trial design

45 participants in 1 patient group

Metformin (all participants)

Description:

Patients with a new indication for Metformin (standard dosage as assigned by the treating physician) therapy. Samples will be collected before and after 12 weeks of Metformin treatment.

Treatment:

Drug: Metformin