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Diabetes mellitus and abnormal glucose tolerance development after gestational diabetes

Diabetes mellitus and abnormal glucose tolerance development after gestational diabetes: a 3-year, prospective, randomised, clinic-based, interventional study with parallel groups

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN24165302
Enrollment
250
Registered
2009-05-29
Start date
2006-01-01
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

Gestational diabetes/diabetes mellitus prevention Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

Eligible women with normal fasting plasma glucose values between 6 and 12 weeks after delivery were randomly assigned to receive: 1. Standard treatment: 1 hour education session and follow up by famil

Sponsors

St Carlos Hospital (Hospital Clínico San Carlos) (Spain)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women diagnosed with gestational diabetes mellitus between 24 and 28 weeks of gestation by Couston and Carpenter criteria between January 2006 and December 2007 2. Normal fasting glucose values (less than 100 mg/dl) between 8 - 12 weeks after delivery

Exclusion criteria

Exclusion criteria: 1. Fasting glucose level greater than 100 mg/dl between 8 - 12 weeks after delivery 2. New gestation during 3-years follow-up

Design outcomes

Primary

MeasureTime frame
Estimation of the conversion rate to abnormal glucose tolerance (type 2 diabetes mellitus, IFG and IGT) of women with prior gestational diabetes mellitus (GDM) and normal fasting glucose values after delivery, measured yearly.

Secondary

MeasureTime frame
Estimation of the changes in: 1. HbA1c 2. Insulin 3. Homestatic model assessment (HOMA) 4. Total (high density lipoprotein [HDL] and low density lipoprotein [LDL]) cholesterol 5. Triglycerides 6. Apolipoprotein B 7. Cytokines 8. Body weight 9. Waist circumference 10. Blood pressure 11. Adherence to changes in lifestyle All outcomes are measured yearly.

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 19, 2026