NCT03301519

Brief Summary

This is a family based genotype-phenotype study designed to assess genetic and environmental influences on obesity, insulin resistance and beta cell function in the context of gestational diabetes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2001

Longer than P75 for all trials

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

July 1, 2001

Completed
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2013

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 4, 2017

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

11.9 years

First QC Date

September 21, 2017

Last Update Submit

November 14, 2023

Conditions

Gestational DiabetesDiabetes Type 2Insulin ResistanceBeta Cell FunctionGeneticsNutritionPhysical ActivityAdipokinesObesityAir Pollution

Outcome Measures

Primary Outcomes (1)

  • Pancreatic Beta Cell Compensation for Insulin Resistance

    Disposition index from intravenous glucose tolerance test

    Single time point for primary cohort, repeated 4.5 years later in subset

Secondary Outcomes (8)

  • Insulin Senstivity

    Single time point for primary cohort, repeated 4.5 years later in subset

  • Acute Insulin Release

    Single time point for primary cohort, repeated 4.5 years later in subset

  • Glucose tolerance

    Single time point for primary cohort, repeated 4.5 years later in subset

  • Diabetes type 2

    Single time point for primary cohort, repeated 4.5 years later in subset

  • Dietary Intake

    Single time point for primary cohort, repeated 4.5 years later in subset

  • +3 more secondary outcomes

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

See Inclusion and Exclusion Criteria

You may qualify if:

  • Probands with Prior Gestational Diabetes Mellitus ("GDM PROBANDS")
  • Mexican American (parents and at least 3/4 four grandparents
  • age \>18 years
  • GDM in singleton pregnancy in prior 5 years
  • impaired glucose levels or sum of five OGTT glucose values \>625 mg/dl on 75 gram oral glucose tolerance test
  • Fasting plasma glucose \<126 mg/dl
  • At least two adult siblings of cousin not known to have diabetes and available for phenotyping; .
  • Siblings and Cousins of GDM Probands
  • Full sibling or first cousin of GDM proband
  • Age \>18 yrs
  • Fasting plasma glucose \<126 mg/dl.
  • Parents, Uncles and Aunts of GDM Probands
  • Full blooded parent, uncle or aunt of GDM proband
  • Control Proband
  • Mexican American as defined for GDM probands
  • +9 more criteria

You may not qualify if:

  • PROBANDS (GDM OR CONTROL):
  • Chronic medical illness or medication known to alter glucose/insulin metabolism
  • Current pregnancy or breastfeeding
  • Ilicit drug or alcohol abuse,
  • Inability or unwillingness to give informed consent.
  • SIBLINGS AND COUSINS OF PROBANDS:
  • Chronic medical illness or medication known to affect glucose/insulin metabolism
  • Current pregnancy or breastfeeding,
  • Ilicit drug or alcohol abuse
  • Inability or unwillingness to give informed consent.
  • PARENTS OF PROBANDS
  • Inability or unwillingness to give informed consent.
  • SPOUSE OF GDM or CONTROL PROBAND
  • Inability or unwillingness to give informed consent.
  • CHILD OF GDM or CONTROL PROBAND
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

DNA, plasma samples from oral glucose tolerance test, plasma samples from intravenous glucose tolerance test

MeSH Terms

Conditions

Diabetes, GestationalDiabetes Mellitus, Type 2Insulin ResistanceMotor ActivityObesity

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismBehaviorOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 21, 2017

First Posted

October 4, 2017

Study Start

July 1, 2001

Primary Completion

May 31, 2013

Study Completion

May 31, 2013

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share