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

Metformin for the treatment of hyperandrogenism in adolescents with type 1 diabetes mellitus: a double blind randomized study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN51650949

Enrollment

Registered

2013-02-06

Start date

2005-01-05

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 d

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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. 2. Metabolic control. HbA1c assessment was performed every three months with blood obtained from capillary puncture of the fingers. 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.	—

Measure

Time frame

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. 2. Metabolic control. HbA1c assessment was performed every three months with blood obtained from capillary puncture of the fingers. 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.

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Countries

Chile

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026