NCT01274052

Brief Summary

The researchers investigated nineteen pregnant women in third trimester and again postpartum. At the experimental days we performed a mealtest and drew blood for analyses of glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), insulin, C-peptide and glucagon. The researchers aimed to investigate whether women with gestational diabetes mellitus exhibit decreased postprandial GLP-1 responses, and if so, whether this deficiency ceases following delivery when normal glucose tolerance is reestablished.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2011

Completed
Last Updated

January 11, 2011

Status Verified

January 1, 2011

Enrollment Period

1.3 years

First QC Date

January 10, 2011

Last Update Submit

January 10, 2011

Conditions

Gestational Diabetes Mellitus

Keywords

Gestational diabetes mellitusMeal testIncretin hormonesGlucagon-like peptide-1 (GLP-1)Glucose-dependent insulinotropic polypeptideInsulinC-peptideGlucagon

Study Arms (2)

Gestational Diabetes Mellitus

Women with Gestational Diabetes Mellitus

Other: Meal test

Normal Glucose Tolerance

Women with Normal Glucose Tolerance

Other: Meal test

Interventions

Meal testOTHER

Liquid meal test

Gestational Diabetes MellitusNormal Glucose Tolerance

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy pregnant woman were examined with a 75 g oral glucose tolerance test. Subjects with plasma glucose (PG) values at 120 min \>9.0 mmol/l were diagnosed with gestational diabetes and subjects with PG \<9.0 mmol/l were enrolled as healthy controls.

You may qualify if:

  • Normal haemoblobin
  • Willingness to participate

You may not qualify if:

  • First degree relative with diabetes
  • Diabetes before pregnancy
  • Positive islet cell- and GAD-65 autoantibodies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Glostrup Hospital

Glostrup Municipality, 2600, Denmark

Location

Related Publications (1)

  • Hare KJ, Bonde L, Svare JA, Randeva HS, Asmar M, Larsen S, Vilsboll T, Knop FK. Decreased plasma chemerin levels in women with gestational diabetes mellitus. Diabet Med. 2014 Aug;31(8):936-40. doi: 10.1111/dme.12436. Epub 2014 Apr 1.

    PMID: 24628007DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Plasma

MeSH Terms

Conditions

Diabetes, GestationalInsulin Resistance

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Filip K Knop, MD PhD

    Diabetes Research Division, Gentofte Hopsital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2011

First Posted

January 11, 2011

Study Start

March 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

January 11, 2011

Record last verified: 2011-01

Locations

DK(1)