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

Completed

• Conditions: Type2 Diabetes; Gestational Diabetes; Life Style

• Registration Number: NCT03050645
• Lead Sponsor: University of Southern Denmark

Brief Summary

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.

Detailed Description

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

1. 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

2. 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):

1. Anthropometrics: weight, height, waist circumference, blood pressure and length

2. 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.

3. 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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-02-10
• Study First Posted: 2017-02-13
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-08
• Last Update Posted: 2017-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 210

Inclusion Criteria

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

Exclusion Criteria

• Bariatric surgery
• Poorly controlled psychiatric disorder

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Type 2 diabetes	7 to 8 years after giving birth

Secondary Outcome Measures

Name	Time	Method
Questionnaires, quality of life (SF12), physical and mental summary scores	7 to 8 years after giving birth
Questionnaires, physical activity (PAS 2), physical activity score	7 to 8 years after giving birth
Plasma glucose (mmol/l) at 0, 30 and 120 minutes during oral glucose tolerance test	7 to 8 years after giving birth
Serum insulin (mU/l) at 0, 30 and 120 minutes during oral glucose tolerance test	7 to 8 years after giving birth
Questionnaires, mental health (WHO-5), WHO-Five well being index	7 to 8 years after giving birth
Body mass index (kg/m2)	7 to 8 years after giving birth
Blood pressure (mmHg)	7 to 8 years after giving birth

Trial Locations

Locations (1)

University of Southern Denmark; 🇩🇰 Odense, Denmark