Metformin for the treatment of hyperandrogenism in adolescents with type 1 diabetes mellitus

Completed

Conditions: Type 1 diabetes
Nutritional, Metabolic, Endocrine
Insulin-dependent diabetes mellitus

Registration Number: ISRCTN51650949

Lead Sponsor: Scientific and Technological Development Fund (FONDECYT Fondo de Desarrollo Científico y Tecnológico) (Chile)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 24

Inclusion Criteria

1. Type 1 diabetes
2. Insufficient metabolic control
3. Clinical or biochemical hyperandrogenism
4. Already had menarche and younger than 22 yr

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
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.<br>2. Metabolic control. HbA1c assessment was performed every three months with blood obtained from capillary puncture of the fingers.<br>3. Ovulatory function. During the nine months protocol, the patients obtained a sample of capillary blood in a filter paper for measurement of progesterone levels and determine the presence of ovulation. The filter paper was obtained in days 18-23-28 of each menstrual cycle. The capillary blood sample was obtained together with the procedure of capillary blood puncture for measuring glucose levels, which the patients do every day.