Ignite Creation Date:
2024-05-06 @ 4:17 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04930471
Status:
UNKNOWN
Last Update Posted:
2021-06-18
First Post:
2021-06-01
Brief Title:
Steroid and Behaviour Changes Under Metformin
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
A Multi-center Prospective Cohort Study to Elucidate the Effects of Metformin Treatment on Steroid Hormones and Social Behavior Linking Autistic Behaviorial Symptoms to Changes in Steroid Hormone Availability
Status:
UNKNOWN
Status Verified Date:
2021-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None