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

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ClinicalTrials.gov Identifier: NCT03050645
Recruitment Status : Completed
First Posted : February 13, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Dorte Moller Jensen, 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.


Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 210 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diabetes, Metabolic Risk Factors, Autoimmunity and Self-reported Life Style Factors in Women With Previous Gestational Diabetes Mellitus (GDM)
Study Start Date : June 2011
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Type 2 diabetes [ Time Frame: 7 to 8 years after giving birth ]

Secondary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Bariatric surgery
  • Poorly controlled psychiatric disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050645


Locations
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Denmark
University of Southern Denmark
Odense, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
Investigators
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Principal Investigator: Dorte M Jensen University of Southern Denmark
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Responsible Party: Dorte Moller Jensen, Ass. prof., University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03050645    
Other Study ID Numbers: University of Southern Denmark
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications