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NCT Number: NCT03050645

Metabolic Risk and Life Style Factors in Women With Previous Gestational Diabetes Mellitus (GDM)

Women with previous Gestational Diabetes Mellitus (GDM) are characterized by several metabolic abnormalities i.e. insulin resistance, beta-cell dysfunction and increased risk of later Diabetes Mellitus (DM). These latent disorders of glucose metabolism are demasked by the metabolic stress of pregnancy and as a routine, clinical assessment and measurement of HbA1c in addition to an oral glucose tolerance test (OGTT) is offered 3 months post partum.

In this study, women with previous GDM and a control group matched on age, time of birth and BMI around 8 years after pregnancy will be investigated. Information from pregnancy and post partum examination (GDM only) will be used to identify risk factors for later development of DM. Further, life-style factors and mental health according to diabetes status will be studied.

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Key information

Conditions

Type2 Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Glucose Metabolism Disorders Life Style Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

University of Southern Denmark

Odense, 5000, Denmark

About this study

Background

It is well established that women with previous GDM are characterized by several metabolic abnormalities i.e. insulin resistance, beta-cell dysfunction and increased risk of later Diabetes Mellitus (DM). Furthermore, GDM is a heterogeneous condition covering both women with a strong genetic disposition to type 2 DM, women in the early stages of autoimmune DM and rare cases of monogenetic DM. These latent disorders of glucose metabolism are damasked by the metabolic stress of pregnancy.

Aims

  • To study predictors of DM and pre-DM after GDM: a) At the time of pregnancy: age, blood pressure, pre-pregnancy Body Mass Index (BMI), b) 3 months post partum: indices of insulin sensitivity and beta-cell function, lipid profile, GAD-autoantibodies, HbA1c
  • To study lifestyle factors 7-8 years after GDM pregnancy in relation to current diabetes status

Materials and methods

During 2011-2017 women with previous GDM and a control group are invited to a long-term follow-up. Data collection is performed 7-8 years after pregnancy. GDM subjects (n~150), controls (n~50):

  • Anthropometrics: weight, height, waist circumference, blood pressure and length
  • Analyses: p-glucose, s-insulin at 0, 30 and 120 minutes during a 2-h 75 g OGTT. Fasting: total cholesterol, HDL, LDL triglycerides, GAD- autoantibodies, Hba1C, Urine albumin/creatinine ratio.
  • Questionnaires: Information on lifestyle and health status

Data available around pregnancy

Pregnancy data from hospital journals (GDM subjects and controls):

Examinations 3 months post-partum (GDM subjects only):

Clinical examination, 2-h 75 g OGTT with measurements of p-glucose and s- insulin at 0, 30 and 120 minutes, fasting total cholesterol, HDL, LDL and triglycerides, HbA1c and GAD- autoantibodies.

Perspectives

Our current population is unique as clinical, metabolic and autoimmune markers were determined prospectively a few months after GDM pregnancy and at follow-up. Hopefully, the results will enable us to target preventive actions in women with previous GDM and improve our understanding of pathophysiologic mechanisms in pre-diabetic conditions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previous GDM with information from post partum OGTT
  • Danish speaking

Exclusion criteria

  • Bariatric surgery
  • Poorly controlled psychiatric disorder

Treatment and study plan

Primary outcomes

  1. Type 2 diabetes

    Time frame: 7 to 8 years after giving birth

Secondary outcomes

  1. Plasma glucose (mmol/l) at 0, 30 and 120 minutes during oral glucose tolerance test

    Time frame: 7 to 8 years after giving birth

  2. Serum insulin (mU/l) at 0, 30 and 120 minutes during oral glucose tolerance test

    Time frame: 7 to 8 years after giving birth

  3. Body mass index (kg/m2)

    Time frame: 7 to 8 years after giving birth

  4. Blood pressure (mmHg)

    Time frame: 7 to 8 years after giving birth

  5. Questionnaires, quality of life (SF12), physical and mental summary scores

    Time frame: 7 to 8 years after giving birth

  6. Questionnaires, mental health (WHO-5), WHO-Five well being index

    Time frame: 7 to 8 years after giving birth

  7. Questionnaires, physical activity (PAS 2), physical activity score

    Time frame: 7 to 8 years after giving birth

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study title

Diabetes, Metabolic Risk Factors, Autoimmunity and Self-reported Life Style Factors in Women With Previous Gestational Diabetes Mellitus (GDM)

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Feb 13, 2017
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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