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

Diabetes, Metabolic Risk Factors, Autoimmunity and Self-reported 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.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes; Gestational Diabetes; Life Style

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 Type: Observational
• Enrollment (Actual): 210

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • University of Southern Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

1. Women with gestational diabetes in a previous pregnancy and information from post partum ogtt.
2. A control Group of women without GDM matched on pre-pregnancy BMI, age and time of birth.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Bariatric surgery
• Poorly controlled psychiatric disorder

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
previous GDM; Women with previous GDM
no previous GDM; Women without previous GDM matched on age, pregestational body mass index end time of pregnancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Type 2 diabetes	7 to 8 years after giving birth

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Body mass index (kg/m2)	7 to 8 years after giving birth
Blood pressure (mmHg)	7 to 8 years after giving birth
Questionnaires, quality of life (SF12), physical and mental summary scores	7 to 8 years after giving birth
Questionnaires, mental health (WHO-5), WHO-Five well being index	7 to 8 years after giving birth
Questionnaires, physical activity (PAS 2), physical activity score	7 to 8 years after giving birth

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Investigators: Principal Investigator: Dorte M Jensen, University of Southern Denmark

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: February 10, 2017
• First Posted (Actual): February 13, 2017

Study Record Updates

• Last Update Posted (Actual): November 9, 2017
• Last Update Submitted That Met QC Criteria: November 8, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: University of Southern Denmark

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED