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Clinical Trials/ISRCTN55443431
ISRCTN55443431
Completed
未知

PostnAtal lifestyle Intervention programme for overweight women with previous GEstational diabetes mellitus (PAIGE)

Belfast Health and Social Care Trust (UK)0 sites100 target enrollmentJune 14, 2013
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ConditionsPostnatal women with a history of gestational diabetes in a recent pregnancy, and who are overweightPregnancy and ChildbirthDiabetes mellitus in pregnancy, unspecified

Overview

Phase
未知
Intervention
Not specified
Conditions
Postnatal women with a history of gestational diabetes in a recent pregnancy, and who are overweight
Sponsor
Belfast Health and Social Care Trust (UK)
Enrollment
100
Status
Completed
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29762737

Registry
who.int
Start Date
June 14, 2013
End Date
December 31, 2014
Last Updated
7 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Belfast Health and Social Care Trust (UK)

Eligibility Criteria

Inclusion Criteria

  • •1\. Aged 18 years or older
  • •2\. History of gestational diabetes mellitus in last pregnancy. The definition of GDM will be according to the new International Association of the Diabetes in Pregnancy Study Groups (IADPSG) consensus criteria (7\), following a 75g oral glucose tolerance test (OGTT) (fasting glucose \=5\.1 mmol/l or 1h plasma glucose \= 10 mmol/l or 2h plasma glucose \=8\.5 mmol/l).
  • •3\. Body mass index (BMI) \= 25 kg/m2 at booking (if less than 16 weeks, otherwise based on reported pre pregnancy weight) and BMI \= 25 kg/m2 at their postnatal OGTT visit. A BMI equivalent to 25 kg/m2 will be used for non Caucasian subjects.
  • •4\. Normal or impaired glucose tolerance or impaired fasting glucose (IFG/IGT) on postnatal glucose tolerance testing.
  • •5\. Mothers will be encouraged to continue to breast feed. The aim will be to recruit mothers who are not planning a further pregnancy in the next 6 months.

Exclusion Criteria

  • •1\. Pregnancy outcome resulting in an anomaly or still birth
  • •2\. History of diabetes outside pregnancy or diagnosis of diabetes on the postnatal OGTT
  • •3\. Heart, liver, or chronic renal disease
  • •4\. Medications that adversely affect glucose tolerance (e.g. steroids)
  • •5\. Contraindications to participating in moderate physical activity
  • •6\. Moderate/severe depressive illness
  • •7\. Excess alcohol consumption
  • •8\. Planning another pregnancy in the next 6 months
  • •9\. Taking part in another research study
  • •10\. Inability to adequately understand verbal explanations or written information given in English, or who have special communication needs

Outcomes

Primary Outcomes

Not specified

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