Steroid and Behaviour Changes Under Metformin

NCT ID: NCT04930471

Last Updated: 2021-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-30

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Autistic Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Metformin (all participants)

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.

Metformin

Intervention Type DRUG

Treatment with Metformin as prescribed by the treating physician.

Interventions

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Metformin

Treatment with Metformin as prescribed by the treating physician.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lindenhofstiftung

UNKNOWN

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Markus G Mohaupt, Professor

Role: STUDY_DIRECTOR

Lindenhofgruppe Berne and Inselspital Berne, Department of Nephrology

Locations

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Lindenhofgruppe

Bern, , Switzerland

Site Status

Countries

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Switzerland

Central Contacts

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Benedikt Gasser, MD

Role: CONTACT

+41788170711

Samuel F Buerki, pract. med.

Role: CONTACT

+41797326198

Facility Contacts

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Markus G Mohaupt, Professor

Role: primary

+41313663111

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Steroid Changes Metformin

Identifier Type: -

Identifier Source: org_study_id

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