Insulin Sensitivity and Secretion During Pregnancy and Post Partum in Women With Gestational Diabetes.

Botnia Clamp in Women Before, Immediately After Delivery and 6 Months Post Partum.

Aim of the study:

To define insulin requirement during pregnancy and to identify the rapid changes in insulin sensitivity around parturition and the first 6 months post partum. Such knowledge would be clinically useful and markedly improve insulin treatment before and after parturition for women with type 1 diabetes and serve to identify the best possible timing of testing women with gestational diabetes mellitus (GDM) for the development of type 2 diabetes post partum.

Method:

Botnia clamp in women before, immediately after delivery and 6 months post partum. The investigators will compare 20 women with GDM in late pregnancy, day 15 post partum and 6 months post partum with 20 normal women investigated at the same time points. In addition the investigators will collect feces samples from the mother and baby in order to determine microbiota.

Perspectives:

Diabetes is a common condition with important implications for pregnancy outcome and long-term morbidity for mother and offspring. Accordingly, tailoring the best treatment is expected to have beneficial consequences both for the pregnant women and the future generation.

Study Overview

• Status: Completed
• Conditions: Diabetes, Gestational

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University Hospital, NBG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

All women visiting the outpatient gestational diabetes clinic at Aarhus University Hospital will be approached.

Description

Inclusion Criteria:

• Written consent before study start.
• Pregnant.
• GDM for the GDM group.
• No diabetes for the control group.

Exclusion Criteria:

• Women with multiple pregnancy.
• New pregnancy before all three examinations has been done.
• Severe, debilitating, concurrent diseases.
• Serious or intolerable adverse reactions associated with the studies.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Gestational diabetes; 10 women with gestational diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in insulin sensitivity	Performing a Botnia clamp 3 times around parturition on women with GDM and comparing them with women with no GDM. The women will be their own control prospectively but also compared with a control group without gestational diabetes in order to compared them cross sectionally	Determined one time between gestational week 32 to 37, 14 days postpartum and 6 months postpartum.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the microbiota	Investigators will ask the participants to bring feces samples from themselves and their baby.	Determined one time between gestational week 32 to 37 (only the mother), 14 days postpartum and 6 months postpartum.

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Per G Ovesen, MD, DMSc, University of Aarhus

Publications and helpful links

General Publications

• Skajaa GO, Fuglsang J, Knorr S, Møller N, Ovesen P, Kampmann U. Changes in insulin sensitivity and insulin secretion during pregnancy and post partum in women with gestational diabetes. BMJ Open Diabetes Res Care. 2020 Oct;8(2). pii: e001728. doi: 10.1136/bmjdrc-2020-001728.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: May 1, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 12, 2016

Study Record Updates

• Last Update Posted (Actual): September 27, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Insulin sensitivity
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational
• Other Study ID Numbers: GDM_Clamp_Skajaa

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No