Metformin for the treatment of hyperandrogenism in adolescents with type 1 diabetes mellitus
| ISRCTN | ISRCTN51650949 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51650949 |
| Protocol serial number | Fondecyt Grant 1050452 |
| Sponsor | Scientific and Technological Development Fund (FONDECYT Fondo de Desarrollo Científico y Tecnológico) (Chile) |
| Funder | Scientific and Technological Development Fund (FONDECYT Fondo de Desarrollo Científico y Tecnológico) (Chile) - Chilean government Grant number: 1050452 |
- Submission date
- 28/01/2013
- Registration date
- 06/02/2013
- Last edited
- 06/02/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
There is an increased prevalence of hyperandrogenism (excessive production of male hormones) in women with type 1 diabetes. We do not know the best treatment for this condition. This study evaluated the effect of an insulin-sensitizing drug called metformin which has been used for the treatment of hyperandrogenism in women without type 1 diabetes. We investigated the effect of metformin on hyperandrogenism and ovulation in adolescents with type 1 diabetes mellitus.
Who can participate?
Women younger than 22 years who have type 1 diabetes and either increased body hair (hirsutism) or elevated androgen plasmatic levels participated.
What does the study involve?
Participants were randomly allocated to take either metformin (850 mg twice a day) or a pill without any medication (placebo twice a day) for nine months. A hormonal study was performed at the beginning and at the end of the study and an assessment of menstrual cycles and presence of ovulation was carried-out throughout the study. No healthy volunteers were included in this study.
What are the possible benefits and risks of participating?
The benefits of participating included a monthly evaluation by a nurse and diabetologist.
Side effects were mainly nausea or abdominal discomfort, at the beginning of the treatment. Metformin has been studied in many adults and adolescents with type 1 diabetes and no major side effects have been reported.
Where is the study run from?
The lead centre taking part in this trial is Instituto de Investigaciones Materno Infantil, School of Medicine, University of Chile. This is an academic centre located in a General Hospital (Hospital San Borja Arriarán) in Santiago, Chile. Some patients were referred from Hospital Calvo Mackena in Santiago, Hospital de Talca and Concepción (Chile).
When is the study starting and how long is it expected to run for?
January 2005 to January 2008.
Who is funding the study?
The study was funded by a Chilean governmental organism, Fondecyt. The support was
started in 2005 and finished in 2008.
Who is the main contact?
Dr. Ethel Codner
ecodner@med.uchile.cl
Contact information
Scientific
Casilla 226-3
Santiago
8360160
Chile
Study information
| Primary study design | Interventional |
|---|---|
| Study design | 9 months double-blind placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Metformin for the treatment of hyperandrogenism in adolescents with type 1 diabetes mellitus: a double blind randomized study |
| Study objectives | It is hypothesized that metformin will be a useful treatment for adolescents with type 1 diabetes and hyperandrogenism. |
| Ethics approval(s) | Chilean Ministry of Health, Central Metropolitan Service, Resolution 24/07, 27 August 2004 |
| Health condition(s) or problem(s) studied | Type 1 diabetes |
| Intervention | Metformin 850 mg twice a day or placebo given twice daily. Total duration of intervention: 9 months Hormonal measurement in a blood sample at the beginning and end of the protocol Menstrual cycle duration and ovulation assessment In order to asses ovulation, measurement of progesterone in blood obtained together with capillary blood glucose measurement. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Metformin |
| Primary outcome measure(s) |
Hyperandrogenism: One blood sample was obtained at the beginning of the trial (baseline) and a second one was obtained at the end of the trial (9 months). |
| Key secondary outcome measure(s) |
1. Hirsutism score. A medical control was performed monthly in order to evaluate hirsutism, and for adjusting insulin dose and check possible side effects. Clinical assessment of hirsutism with a visual scale, Ferriman-Gallwey score, was performed monthly. |
| Completion date | 03/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 24 |
| Key inclusion criteria | 1. Type 1 diabetes 2. Insufficient metabolic control 3. Clinical or biochemical hyperandrogenism 4. Already had menarche and younger than 22 yr |
| Key exclusion criteria | 1. Type 2 or other type of diabetes. 2. Honeymoon period defined as an insulin daily requirement lower than 0.5 U/kg/day and HbA1c lower than 7%. 3. Diabetes duration less than 1.5 years 4. Abnormal thyroid function; elevated creatinine level 5. Use of contraceptive pills, steroids or any other type of medication 6. Presence of other chronic conditions |
| Date of first enrolment | 05/01/2005 |
| Date of final enrolment | 03/01/2008 |
Locations
Countries of recruitment
- Chile
Study participating centre
8360160
Chile
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | 01/09/2009 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
