Effects of Metformin on Androgens and Other Steroid Hormones in Affected Subjects With Autism

NCT06762041 | Not Yet Recruiting

• 2 other identifiers: SteroidlabsLindenhofhospital Berne
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Autism is diagnosed with increasing frequency in recent years despite remaining uncertainty concerning the cause. The disorder is characterized by deficits in social behavior, a lack of communication skills, and repetitive and stereotypical interests. As part of the research, It attempted to pursue the hypothesis that the disorder is signed by an endocrine involvement. Therefore, the original description of Hans Asperger was analyzed first. This was followed by comprehensive steroid hormone analyses in girls and boys with autism. Based on the assumption that steroid hormones are involved, dysregulation of the adrenal gland for all metabolite classes - mineralocorticoid, glucocorticoid, androgen - were identified. The subsequently followed animal experiments yielded to the conclusion that a dysregulation of the hypothalamic-pituitary system might be responsible for the autistic behavior. This is also probably associated with overactivity of 17/20 lyase, an orchestrating enzyme of oxidative stress, which is driven by p38. It is suspected that the increased oxidative stress is of mitochondrial origin and thus other metabolic cascades are involved. Due to the developed understanding of the suspected dysregulation, new therapeutic options for treatment are opening up, with metformin in particular - known for its antiandrogenic effect used in poly cystic ovarian syndrome - appearing to have the best effect on social withdrawal in the developed mouse model. Initial urine analyses allow the assumption that metformin directly influences steroidogenesis, and thus opens up the possibility of a clinical trial for affected subjects with autism.

Conditions

Autism

Outcome Measures

Primary Outcomes (1)

• Steroid hormone concentrations of total androgens

  Steroid hormones

  After 6-9 month of treatment with Metformin

Study Arms (1)

Metformin Treatment

Drug: Metformin treatment

Interventions

Metformin treatment DRUG

Interested subjects with autism are treated with metformin with a standard dosage

Also known as: Metformin treatment in subjects with autism

Metformin Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with autism

You may qualify if:

• Diagnosis with autism according to DSM-V.
• Written informed consent

You may not qualify if:

• Clinically significant concomitant disease states (e.g. advanced renal failure, hepatic Dysfunction - risk factor of lactate acidosis)
• Significant musculoskeletal disease
• Active infection
• Immunosuppressive medical therapy
• Known or suspected non-compliance, drug or alcohol abuse
• Pregnant or breastfeeding mothers are excluded
• Inability to follow the procedures of the study, e.g. due to insufficient language skills, psychological disorders, very severe dementia inability to report adequately

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Related Publications (4)

• Gasser BA, Kurz J, Dick B, Mohaupt MG. Steroid Metabolites Support Evidence of Autism as a Spectrum. Behav Sci (Basel). 2019 May 9;9(5):52. doi: 10.3390/bs9050052.

  PMID: 31075898 BACKGROUND

• Gasser BA, Kurz J, Senn W, Escher G, Mohaupt MG. Stress-induced alterations of social behavior are reversible by antagonism of steroid hormones in C57/BL6 mice. Naunyn Schmiedebergs Arch Pharmacol. 2021 Jan;394(1):127-135. doi: 10.1007/s00210-020-01970-7. Epub 2020 Sep 7.

  PMID: 32894324 BACKGROUND

• Gasser B, Escher G, Calin AE, Deppeler M, Marchon M, Kurz J, Mohaupt M. Are steroid hormones and autistic traits affected by metformin? First insights from a pilot. Compr Psychoneuroendocrinol. 2023 Jul 29;16:100196. doi: 10.1016/j.cpnec.2023.100196. eCollection 2023 Nov.

  PMID: 37577184 BACKGROUND

• Gasser B, Escher G, Calin AE, Deppeler M, Marchon M, Mistry HD, Kurz J, Mohaupt MG. Prior to versus after Metformin Treatment-Effects on Steroid Enzymatic Activities. Life (Basel). 2023 Apr 27;13(5):1094. doi: 10.3390/life13051094.

  PMID: 37240739 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Steroid hormone concentrations

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Markus Mohaupt, Prof. Dr.

  University of Berne

  STUDY DIRECTOR

Central Study Contacts

Benedikt A Gasser, Dr. Dr,med

CONTACT

+41 0788170711; benedikt.gasser@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: January 7, 2025
• Study Start: January 30, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share