Clinical trial NCT04222348: MeDiGes Study: Metformine Use in Gestational Diabetes
Official title: Efficacy of Metformin Treatment in Not Controlled With Diet Gestational Diabetes Versus Use of Insulin Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetes, Gestational
Perinatal Disorder
Puerperal Disorder
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Inferiority, randomized, open, parallel arms, multicenter clinical trial
Primary purpose: TREATMENT

Brief summary: Women with gestational diabete (GD) who do not meet glycemic control objectives with diet will be assigned to two treatment groups randomly. One: metformin at a dose of 850-2550mg every 24h; two: insulin detemir associated or not with rapid insulin analogue (aspart) according to your glycemic controls. The Metformin group may additionally receive insulin in a second time in case the glycemic control is not appropriate with monotherapy.

Detailed description: Women with gestational diabete (GD) who do not meet glycemic control objectives with diet will be assigned to two treatment groups randomly. One: metformin at a dose of 850-2550mg every 24h; two: insulin detemir associated or not with rapid insulin analogue (aspart) according to your glycemic controls. The Metformin group may additionally receive insulin in a second time in case the glycemic control is not appropriate with monotherapy.

The objectives are: Demonstrate that treatment with metformin in women with GD (not controlled with diet) can get no lower obstetric and perinatal outcomes than those with standard treatment with insulin.

Demonstrate that glycemic control with metformin in properly selected women, can be equivalent to that obtained with insulin.

Eligibility criteria: Inclusion Criteria:

1. 18-45 years old.
2. Diagnosis of GD, with fasting glucose \<120 mg / dL.
3. not controlled by diet: fasting capillary blood glucose\> 95 mg / dl in at least 2-3 times or 1 hour postprandial \>140 mg / dl on, at least 2-3 times a week.
4. 2nd or 3rd trimesters of pregnancy.
5. Able to give informed consent.

Exclusion Criteria:

1. Psychopathological situations that do not guarantee proper adhesion to follow up
2. 1st trimester of pregnancy
3. gastrointestinal diseases that may cause poorer tolerance or increased symptoms with metformin.
4. Patients who can not attend the scheduled consultation.
5. Language barrier limiting for understanding treatment settings
6. Twin pregnancy.

Primary outcomes:
measure: Metformin benefits
timeFrame: 50 weeks
measure: Good glycemic control
timeFrame: 50 weeks
measure: Baby wellness
timeFrame: Delivery
Secondary outcomes:
measure: Adverse event profile
timeFrame: 50 weeks
measure: Fructosamine as a marker of insulinization
timeFrame: 50 weeks
measure: Satisfaction with the treatment
timeFrame: 50 weeks
measure: IL-6 profile
timeFrame: 50 weeks
measure: IL-10 profile and oxidativge stress as well as in lipid profile
timeFrame: 50 weeks
measure: Leptin profile
timeFrame: 50 weeks
measure: Ladiponectin and oxidativge stress as well as in lipid profile
timeFrame: 50 weeks
measure: LPS profile
timeFrame: 50 weeks
measure: LBP profile and oxidativge stress as well as in lipid profile
timeFrame: 50 weeks
Other outcomes:
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