The Incretin Effect in Patients With Gestational Diabetes Mellitus

This study has been completed.
Sponsor:
Collaborator:
University of Copenhagen
Information provided by:
Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT01307995
First received: March 2, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

The aim of this study is to evaluate the reduced incretin effect observed in patients with T2DM in relation to reversibility. The incretin effect will be measured by means of OGTT and iIVGTT in 12 women with GDM during pregnancy (third trimester), and again 2-3 months post partum. It is anticipated that the incretin effect in patients with GDM is reduced - like in patients with other forms of DM. The investigators estimate that approximately 90 % of the patients with GDM re-establish a NGT 2-3 months post partum. This particular group of patients provides a unique possibility for demonstrating the reversibility of the reduced incretin effect in relation to optimal glycaemic control.


Condition
Gestational Diabetes

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Official Title: Observational Study to Evaluate the Reduced Incretin Effect Observed in Patients With GDM in Relation to Reversibility After a Delivery.

Resource links provided by NLM:


Further study details as provided by Medical Universtity of Lodz:

Enrollment: 20
Study Start Date: April 2007
Study Completion Date: May 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
GDM
Patients with Gestational Diabetes Mellitus found during pregnancy by means of 75g OGTT
NGT
Pregnant patients with normal glucose tolerance as observed in 75g OGTT

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Pregnant women above the age of 18 years with GDM) (Controls: pregnant women above the age of 18 years with NGT)

Criteria

Inclusion Criteria:

  • age above 18 years old
  • GDM diagnosed according to WHO guidelines (GDM group) or ruled out by OGTT 75g (Control group)

Exclusion Criteria:

  • Previous diagnosis of DM
  • Positive GAD-65-autoantibodies and/or positive islet cell autoantibodies (ICA)
  • Affected biochemical liver parameters (ALAT > 2 times normal upper range)
  • Affected biochemical kidney parameters (se-creatinine > 130 µM)
  • Treatment with medicine interacting with insulin secretion (e.g. steroids)
  • Treatment with medicine that can not be paused for 16 hours
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01307995

Locations
Poland
Departament of Diabetology and Metabolic Diseases, Polish Mothers Research Hospital
Lodz, Poland, 93-338
Sponsors and Collaborators
Medical Universtity of Lodz
University of Copenhagen
Investigators
Study Director: Katarzyna Cypryk, MD, PhD, Asoc. Prof. Medical University Lodz
Study Director: Tina Vilsbøll, MD, DMSc University of Copenhagen
Principal Investigator: Marcin Kosiński, MD, PhD Medical University Lodz
  More Information

No publications provided

Responsible Party: Marcin Kosinski, Diabetology and Metabolic Diseases Departament
ClinicalTrials.gov Identifier: NCT01307995     History of Changes
Other Study ID Numbers: GDM-INK
Study First Received: March 2, 2011
Last Updated: March 2, 2011
Health Authority: Poland: Ethics Committee

Keywords provided by Medical Universtity of Lodz:
GDM
incretin effect
gestation
reversibility

Additional relevant MeSH terms:
Diabetes, Gestational
Diabetes Mellitus
Pregnancy Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014