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

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03050645
• Other study ID #: University of Southern Denmark
• Status: Completed
• Phase: N/A
• First received: January 4, 2017
• Last updated: November 8, 2017
• Start date: June 2011
• Est. completion date: August 2017

Study information

• Verified date: November 2017
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Previous GDM with information from post partum OGTT

• Danish speaking

Exclusion Criteria:

• Bariatric surgery

• Poorly controlled psychiatric disorder

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Life Style
• Type2 Diabetes

Locations

Country	Name	City	State
Denmark	University of Southern Denmark	Odense

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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