Autistic DisorderNCT04930471
Steroid and Behaviour Changes Under Metformin
An observational study of Autistic Disorder, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- Metformin
- How many people
- 45 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2021to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of the the Lindenhofgruppe and its associated practices with a new indication for Metformin treatment.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
Lindenhofgruppe
Bern, 3012
Markus G Mohaupt, Professor, +41313663111, markus.mohaupt@lindenhofgruppe.ch
About this study
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
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.
Read more
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.
- Conditions
- Autistic Disorder
- Being tested
- Metformin
- Keywords
- Steroid hormones, GC-MS, urine analysis, androgens, autism spectrum disorders
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Treatment with Metformin as prescribed by the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in GC-MS measured urinary androgen metabolite levels.
Changes in urinary androgen metabolite levels of interest (see below) prior to metformin treatment start and after 12-weeks of treatment.
Hormones of interest include Androgen-Metabolites (Androsterone, Androstenediol, 11-Oxoetiocholanolone, 11β-Hydroxyandrosterone, 11β-Hydroxyetiocholanolone, Dehydroepiandrosterone, 5-Androstene-3β,17β-diol, 16α-Hydroxydehydroepiandrosterone, 5-Androstene-3β,16α,17β-triol, 5-Pregnene-3β, 16α,17β-triol, Testosterone, 5α-Dihydrotestosterone). All will be measured in urinary samples using GC-MS (gas-chromatography mass-spectrometry).
Measured: After 12 weeks follow-up
Changes in GC-MS measured urinary oestrogen metabolite levels.
Changes in urinary oestrogen metabolite levels of interest (see below) prior to metformin treatment start and after 12-weeks of treatment.
Hormones of interest include Oestrogen-Metabolites (Estriol, 17b-Estradiol), Progesterone-Metabolites (17-Hydroxypregnanolone, Pregnanediol, Pregnanetriol, 11-Oxo-Pregnanetriol). All wil be measured in urinary samples using GC-MS (gas-chromatography mass-spectrometry).
Measured: After 12 weeks follow-up
Changes in GC-MS measured urinary progesterone metabolite levels.
Changes in urinary progesterone metabolite levels of interest (see below) prior to metformin treatment start and after 12-weeks of treatment.
Hormones of interest include Progesterone-Metabolites (17-Hydroxypregnanolone, Pregnanediol, Pregnanetriol, 11-Oxo-Pregnanetriol).
All wil be measured in urinary samples using GC-MS (gas-chromatography mass-spectrometry).
Measured: After 12 weeks follow-up
Changes in GC-MS measured urinary aldosterone metabolite levels.
Changes in urinary aldosterone metabolite levels of interest (see below) prior to metformin treatment start and after 12-weeks of treatment.
Hormones of interest include Aldosterone-Metabolites (Tetrahydroaldosterone). All wil be measured in urinary samples using GC-MS (gas-chromatography mass-spectrometry).
Measured: After 12 weeks follow-up
Changes in GC-MS measured urinary corticosterone metabolite levels.
Changes in urinary corticosterone metabolite levels of interest (see below) prior to metformin treatment start and after 12-weeks of treatment.
Hormones of interest include Corticosterone-Metabolites (TetrahydroDOC, Tetrahydrodehydrocorticosterone, Tetrahydrocorticosterone, 5a-Tetrahydrocorticosterone, 18-Hydroxy-tetrahydrocompound A, Cortisone).
All wil be measured in urinary samples using GC-MS (gas-chromatography mass-spectrometry).
Measured: After 12 weeks follow-up
Changes in GC-MS measured urinary cortisone metabolite levels.
Changes in urinary cortisone metabolite levels of interest (see below) prior to metformin treatment start and after 12-weeks of treatment.
Hormones of interest include Cortisone-Metabolites (Tetrahydrocortisone, a-Cortolone, b-Cortolone, 20a-Dihydrocortisone, 20b-Dihydrocortisone).
All wil be measured in urinary samples using GC-MS (gas-chromatography mass-spectrometry).
Measured: After 12 weeks follow-up
Changes in GC-MS measured urinary cortisol metabolite levels.
Changes in urinary cortisol metabolite levels of interest (see below) prior to metformin treatment start and after 12-weeks of treatment.
Hormones of interest include Cortisol-Metabolites (Cortisol, Tetrahydrocortisol, 5a-Tetrahydrocortisol, a-Cortol, b-Cortol, 20a-Dihydrocortisol, 6b-Hydroxycortisol, 18-Hydroxycortisol).
All wil be measured in urinary samples using GC-MS (gas-chromatography mass-spectrometry).
Measured: After 12 weeks follow-up
Behavioral Changes
Changes in social behavior measured by the Autism-Spectrum Quotient AQ prior to metformin treatment start and after 12-weeks of treatment.
Measured: After 12 weeks follow-up
Secondary outcomes (1)
Correlation between urinary steroid hormone level changes (metabolites of androgen, oestrogen, progesterone, aldosterone, corticosterone, cortisone and cortisol) and behavioral changes measured with pearson correlation coefficient.
A potential correlation and/or dosage effect between the primary outcomes will be evaluated using the pearson correlation coefficient.
Measured: After 12 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study startJun 2021 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (60)Papers the sponsor has linked to this study.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Lindenhofstiftung
- Responsible party
- Sponsor
- Investigators
- Markus G Mohaupt, Professor, Study director, Lindenhofgruppe Berne and Inselspital Berne, Department of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930471
- Sponsor's protocol ID
- Steroid Changes Metformin
- Status last verified
- Jun 2021
- First submitted
- 1 Jun 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andonian MR, Barrett AS, Vinogradov SN. Physical properties and subunits of Haemopis grandis erythrocruorin. Biochim Biophys Acta. 1975 Dec 15;412(2):202-13. doi: 10.1016/0005-2795(75)90035-5.
PubMed 84Aufdenblatten M, Baumann M, Raio L, Dick B, Frey BM, Schneider H, Surbek D, Hocher B, Mohaupt MG. Prematurity is related to high placental cortisol in preeclampsia. Pediatr Res. 2009 Feb;65(2):198-202. doi: 10.1203/PDR.0b013e31818d6c24.
PubMed 19047954Azziz R. Androgen excess is the key element in polycystic ovary syndrome. Fertil Steril. 2003 Aug;80(2):252-4. doi: 10.1016/s0015-0282(03)00735-0. No abstract available.
PubMed 12909479Baillargeon JP, Jakubowicz DJ, Iuorno MJ, Jakubowicz S, Nestler JE. Effects of metformin and rosiglitazone, alone and in combination, in nonobese women with polycystic ovary syndrome and normal indices of insulin sensitivity. Fertil Steril. 2004 Oct;82(4):893-902. doi: 10.1016/j.fertnstert.2004.02.127.
PubMed 15482765Baron-Cohen S, Wheelwright S, Skinner R, Martin J, Clubley E. The autism-spectrum quotient (AQ): evidence from Asperger syndrome/high-functioning autism, males and females, scientists and mathematicians. J Autism Dev Disord. 2001 Feb;31(1):5-17. doi: 10.1023/a:1005653411471.
PubMed 11439754Biag HMB, Potter LA, Wilkins V, Afzal S, Rosvall A, Salcedo-Arellano MJ, Rajaratnam A, Manzano-Nunez R, Schneider A, Tassone F, Rivera SM, Hagerman RJ. Metformin treatment in young children with fragile X syndrome. Mol Genet Genomic Med. 2019 Nov;7(11):e956. doi: 10.1002/mgg3.956. Epub 2019 Sep 14.
PubMed 31520524Bishop DV, Maybery M, Maley A, Wong D, Hill W, Hallmayer J. Using self-report to identify the broad phenotype in parents of children with autistic spectrum disorders: a study using the Autism-Spectrum Quotient. J Child Psychol Psychiatry. 2004 Nov;45(8):1431-6. doi: 10.1111/j.1469-7610.2004.00849.x.
PubMed 15482503Brandt EJ, Elliott RW, Swank RT. Defective lysosomal enzyme secretion in kidneys of Chediak-Higashi (beige) mice. J Cell Biol. 1975 Dec;67(3):774-88. doi: 10.1083/jcb.67.3.774.
PubMed 408Burghen GA, Givens JR, Kitabchi AE. Correlation of hyperandrogenism with hyperinsulinism in polycystic ovarian disease. J Clin Endocrinol Metab. 1980 Jan;50(1):113-6. doi: 10.1210/jcem-50-1-113.
PubMed 7350174Campagnoli C, Abba C, Ambroggio S, Brucato T, Pasanisi P. Life-style and metformin for the prevention of endometrial pathology in postmenopausal women. Gynecol Endocrinol. 2013 Feb;29(2):119-24. doi: 10.3109/09513590.2012.706671. Epub 2012 Sep 5.
PubMed 22946682Chakrabarti B, Dudbridge F, Kent L, Wheelwright S, Hill-Cawthorne G, Allison C, Banerjee-Basu S, Baron-Cohen S. Genes related to sex steroids, neural growth, and social-emotional behavior are associated with autistic traits, empathy, and Asperger syndrome. Autism Res. 2009 Jun;2(3):157-77. doi: 10.1002/aur.80.
PubMed 19598235Chang RJ, Nakamura RM, Judd HL, Kaplan SA. Insulin resistance in nonobese patients with polycystic ovarian disease. J Clin Endocrinol Metab. 1983 Aug;57(2):356-9. doi: 10.1210/jcem-57-2-356.
PubMed 6223044Chaoui R, Bollmann R, Zienert A, Weichold K, Goldner B, Semmler K. [Prenatal diagnosis of truncus arteriosus communis (type I) in diabetic pregnancy]. Zentralbl Gynakol. 1992;114(4):198-200. German.
PubMed 1621459Chou KH, von Eye Corleta H, Capp E, Spritzer PM. Clinical, metabolic and endocrine parameters in response to metformin in obese women with polycystic ovary syndrome: a randomized, double-blind and placebo-controlled trial. Horm Metab Res. 2003 Feb;35(2):86-91. doi: 10.1055/s-2003-39056.
PubMed 12734787Cibula D, Fanta M, Vrbikova J, Stanicka S, Dvorakova K, Hill M, Skrha J, Zivny J, Skrenkova J. The effect of combination therapy with metformin and combined oral contraceptives (COC) versus COC alone on insulin sensitivity, hyperandrogenaemia, SHBG and lipids in PCOS patients. Hum Reprod. 2005 Jan;20(1):180-4. doi: 10.1093/humrep/deh588. Epub 2004 Dec 2.
PubMed 15576394
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04930471
- Acronym / sponsor ID
- Steroid Changes Metformin
- Conditions
- Autistic Disorder
- Keywords
- Steroid hormones, GC-MS, urine analysis, androgens, autism spectrum disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Lindenhofstiftung
- Study start
- Jun 2021 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin (all participants) | – | Drug: MetforminPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the the Lindenhofgruppe and its associated practices with a new indication for Metformin treatment.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminTreatment with Metformin as prescribed by the treating physician. | Drug | Metformin (all participants) |
Primary outcome
Changes in GC-MS measured urinary androgen metabolite levels.
Time frame: After 12 weeks follow-up
Changes in urinary androgen metabolite levels of interest (see below) prior to metformin treatment start and after 12-weeks of treatment. Hormones of interest include Androgen-Metabolites (Androsterone, Androstenediol, 11-Oxoetiocholanolone, 11β-Hydroxyandrosterone, 11β-Hydroxyetiocholanolone, Dehydroepiandrosterone, 5-Androstene-3β,17β-diol, 16α-Hydroxydehydroepiandrosterone, 5-Androstene-3β,16α,17β-triol, 5-Pregnene-3β, 16α,17β-triol, Testosterone, 5α-Dihydrotestosterone). All will be measured in urinary samples using GC-MS (gas-chromatography mass-spectrometry).
Changes in GC-MS measured urinary oestrogen metabolite levels.
Time frame: After 12 weeks follow-up
Changes in urinary oestrogen metabolite levels of interest (see below) prior to metformin treatment start and after 12-weeks of treatment. Hormones of interest include Oestrogen-Metabolites (Estriol, 17b-Estradiol), Progesterone-Metabolites (17-Hydroxypregnanolone, Pregnanediol, Pregnanetriol, 11-Oxo-Pregnanetriol). All wil be measured in urinary samples using GC-MS (gas-chromatography mass-spectrometry).
Changes in GC-MS measured urinary progesterone metabolite levels.
Time frame: After 12 weeks follow-up
Changes in urinary progesterone metabolite levels of interest (see below) prior to metformin treatment start and after 12-weeks of treatment. Hormones of interest include Progesterone-Metabolites (17-Hydroxypregnanolone, Pregnanediol, Pregnanetriol, 11-Oxo-Pregnanetriol). All wil be measured in urinary samples using GC-MS (gas-chromatography mass-spectrometry).
Changes in GC-MS measured urinary aldosterone metabolite levels.
Time frame: After 12 weeks follow-up
Changes in urinary aldosterone metabolite levels of interest (see below) prior to metformin treatment start and after 12-weeks of treatment. Hormones of interest include Aldosterone-Metabolites (Tetrahydroaldosterone). All wil be measured in urinary samples using GC-MS (gas-chromatography mass-spectrometry).
Changes in GC-MS measured urinary corticosterone metabolite levels.
Time frame: After 12 weeks follow-up
Changes in urinary corticosterone metabolite levels of interest (see below) prior to metformin treatment start and after 12-weeks of treatment. Hormones of interest include Corticosterone-Metabolites (TetrahydroDOC, Tetrahydrodehydrocorticosterone, Tetrahydrocorticosterone, 5a-Tetrahydrocorticosterone, 18-Hydroxy-tetrahydrocompound A, Cortisone). All wil be measured in urinary samples using GC-MS (gas-chromatography mass-spectrometry).
Changes in GC-MS measured urinary cortisone metabolite levels.
Time frame: After 12 weeks follow-up
Changes in urinary cortisone metabolite levels of interest (see below) prior to metformin treatment start and after 12-weeks of treatment. Hormones of interest include Cortisone-Metabolites (Tetrahydrocortisone, a-Cortolone, b-Cortolone, 20a-Dihydrocortisone, 20b-Dihydrocortisone). All wil be measured in urinary samples using GC-MS (gas-chromatography mass-spectrometry).
Changes in GC-MS measured urinary cortisol metabolite levels.
Time frame: After 12 weeks follow-up
Changes in urinary cortisol metabolite levels of interest (see below) prior to metformin treatment start and after 12-weeks of treatment. Hormones of interest include Cortisol-Metabolites (Cortisol, Tetrahydrocortisol, 5a-Tetrahydrocortisol, a-Cortol, b-Cortol, 20a-Dihydrocortisol, 6b-Hydroxycortisol, 18-Hydroxycortisol). All wil be measured in urinary samples using GC-MS (gas-chromatography mass-spectrometry).
Behavioral Changes
Time frame: After 12 weeks follow-up
Changes in social behavior measured by the Autism-Spectrum Quotient AQ prior to metformin treatment start and after 12-weeks of treatment.
1 secondary outcome
Correlation between urinary steroid hormone level changes (metabolites of androgen, oestrogen, progesterone, aldosterone, corticosterone, cortisone and cortisol) and behavioral changes measured with pearson correlation coefficient.
Time frame: After 12 weeks follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Background: PubMed 84Andonian MR, Barrett AS, Vinogradov SN. Physical properties and subunits of Haemopis grandis erythrocruorin. Biochim Biophys Acta. 1975 Dec 15;412(2):202-13. doi: 10.1016/0005-2795(75)90035-5.
- Background: PubMed 19047954Aufdenblatten M, Baumann M, Raio L, Dick B, Frey BM, Schneider H, Surbek D, Hocher B, Mohaupt MG. Prematurity is related to high placental cortisol in preeclampsia. Pediatr Res. 2009 Feb;65(2):198-202. doi: 10.1203/PDR.0b013e31818d6c24.
- Background: PubMed 12909479Azziz R. Androgen excess is the key element in polycystic ovary syndrome. Fertil Steril. 2003 Aug;80(2):252-4. doi: 10.1016/s0015-0282(03)00735-0. No abstract available.
- Background: PubMed 15482765Baillargeon JP, Jakubowicz DJ, Iuorno MJ, Jakubowicz S, Nestler JE. Effects of metformin and rosiglitazone, alone and in combination, in nonobese women with polycystic ovary syndrome and normal indices of insulin sensitivity. Fertil Steril. 2004 Oct;82(4):893-902. doi: 10.1016/j.fertnstert.2004.02.127.
- Background: PubMed 11439754Baron-Cohen S, Wheelwright S, Skinner R, Martin J, Clubley E. The autism-spectrum quotient (AQ): evidence from Asperger syndrome/high-functioning autism, males and females, scientists and mathematicians. J Autism Dev Disord. 2001 Feb;31(1):5-17. doi: 10.1023/a:1005653411471.
- Background: PubMed 31520524Biag HMB, Potter LA, Wilkins V, Afzal S, Rosvall A, Salcedo-Arellano MJ, Rajaratnam A, Manzano-Nunez R, Schneider A, Tassone F, Rivera SM, Hagerman RJ. Metformin treatment in young children with fragile X syndrome. Mol Genet Genomic Med. 2019 Nov;7(11):e956. doi: 10.1002/mgg3.956. Epub 2019 Sep 14.
- Background: PubMed 15482503Bishop DV, Maybery M, Maley A, Wong D, Hill W, Hallmayer J. Using self-report to identify the broad phenotype in parents of children with autistic spectrum disorders: a study using the Autism-Spectrum Quotient. J Child Psychol Psychiatry. 2004 Nov;45(8):1431-6. doi: 10.1111/j.1469-7610.2004.00849.x.
- Background: PubMed 408Brandt EJ, Elliott RW, Swank RT. Defective lysosomal enzyme secretion in kidneys of Chediak-Higashi (beige) mice. J Cell Biol. 1975 Dec;67(3):774-88. doi: 10.1083/jcb.67.3.774.
- Background: PubMed 7350174Burghen GA, Givens JR, Kitabchi AE. Correlation of hyperandrogenism with hyperinsulinism in polycystic ovarian disease. J Clin Endocrinol Metab. 1980 Jan;50(1):113-6. doi: 10.1210/jcem-50-1-113.
- Background: PubMed 22946682Campagnoli C, Abba C, Ambroggio S, Brucato T, Pasanisi P. Life-style and metformin for the prevention of endometrial pathology in postmenopausal women. Gynecol Endocrinol. 2013 Feb;29(2):119-24. doi: 10.3109/09513590.2012.706671. Epub 2012 Sep 5.
- Background: PubMed 19598235Chakrabarti B, Dudbridge F, Kent L, Wheelwright S, Hill-Cawthorne G, Allison C, Banerjee-Basu S, Baron-Cohen S. Genes related to sex steroids, neural growth, and social-emotional behavior are associated with autistic traits, empathy, and Asperger syndrome. Autism Res. 2009 Jun;2(3):157-77. doi: 10.1002/aur.80.
- Background: PubMed 6223044Chang RJ, Nakamura RM, Judd HL, Kaplan SA. Insulin resistance in nonobese patients with polycystic ovarian disease. J Clin Endocrinol Metab. 1983 Aug;57(2):356-9. doi: 10.1210/jcem-57-2-356.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus G Mohaupt, Professor study director
Lindenhofgruppe Berne and Inselspital Berne, Department of Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autistic Disorder, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benedikt Gasser, MD (+41788170711, benedikt.gasser@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in GC-MS measured urinary androgen metabolite levels. (time frame: After 12 weeks follow-up). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04930471, which also lists 60 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021; AzTrials last refreshed its copy on 30 Oct 2026.