Response of Individuals With Ataxia-Telangiectasia to Metformin and Pioglitazone

Plain-language summary

This study examines the drugs Metformin and Pioglitazone in individuals with ataxia-telangiectasia (an inherited nervous system disorder). Non-diabetic people aged 18 to 30 with a diagnosis of 'classic' ataxia-telangiectasia, along with a control group for comparison, could take part. It was conducted in Phase 4 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Completed

Sponsor

NHS Tayside

Intervention

Metformin, Pioglitazone

Start date

9/29/2016

Estimated completion

8/30/2017

Countries

United Kingdom

Related genes

Locations

• Dundee, United Kingdom

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Age 18 - 30
* White European descent
* Non-diabetic
* No history of malignancy
* Normal renal function (eGFR \> 60 ml/min/1.73m2)
* CASES - Diagnosis of 'classic' Ataxia Telangiectasia (as opposed to 'mild-variant', or related conditions e.g. AOA1)
* CONTROLS - Sex matched to cases
* CONTROLS - BMI 20-25

Exclusion Criteria:

* HbA1c ≥ 48mmol/mol.
* Age out-with 18 - 30
* CASES - Unconfirmed diagnosis of A-T, or non-'classic' form of A-T
* History of diabetes
* History of renal dysfunction
* History of malignancy
* History of heart failure
* Long-term steroid treatment
* Chronic lung infections / bronchiectasis
* Recent (\<30 days since completion) or current participation in another clinical trial or interventional study
* Pregnancy
* Athletes (as muscles mass has a direct effect on insulin sensitivity)