Clinical trial NCT03050645: Metabolic Risk and Life Style Factors in Women With Previous Gestational Diabetes Mellitus (GDM)
Official title: Diabetes, Metabolic Risk Factors, Autoimmunity and Self-reported Life Style Factors in Women With Previous Gestational Diabetes Mellitus (GDM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type2 Diabetes
Gestational Diabetes
Life Style
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2017-02-13
Enrollment: 210
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Bariatric surgery
* Poorly controlled psychiatric disorder

Primary outcomes:
measure: Type 2 diabetes
timeFrame: 7 to 8 years after giving birth
Secondary outcomes:
measure: Plasma glucose (mmol/l) at 0, 30 and 120 minutes during oral glucose tolerance test
timeFrame: 7 to 8 years after giving birth
measure: Serum insulin (mU/l) at 0, 30 and 120 minutes during oral glucose tolerance test
timeFrame: 7 to 8 years after giving birth
measure: Body mass index (kg/m2)
timeFrame: 7 to 8 years after giving birth
measure: Blood pressure (mmHg)
timeFrame: 7 to 8 years after giving birth
measure: Questionnaires, quality of life (SF12), physical and mental summary scores
timeFrame: 7 to 8 years after giving birth
measure: Questionnaires, mental health (WHO-5), WHO-Five well being index
timeFrame: 7 to 8 years after giving birth
measure: Questionnaires, physical activity (PAS 2), physical activity score
timeFrame: 7 to 8 years after giving birth
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark
Study officials:
affiliation: University of Southern Denmark
name: Dorte M Jensen
role: PRINCIPAL_INVESTIGATOR
References: