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

NCT02770079 | Completed DMC

• 1 other identifier: GDM_Clamp_Skajaa
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes, Gestational

Keywords

Insulin sensitivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in the microbiota

  Determined one time between gestational week 32 to 37 (only the mother), 14 days postpartum and 6 months postpartum.

Study Arms (1)

Gestational diabetes

10 women with gestational diabetes

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital, NBG

Aarhus, 8000, Denmark

Location

Related Publications (1)

• Skajaa GO, Fuglsang J, Knorr S, Moller 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):e001728. doi: 10.1136/bmjdrc-2020-001728.

  PMID: 33115822 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood approximately 10 mL.

MeSH Terms

Conditions

Diabetes, Gestational; Insulin Resistance

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Per G Ovesen, MD, DMSc

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2016
• First Posted: May 12, 2016
• Study Start: May 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 27, 2019

Record last verified: 2019-09

Locations

DK (1)