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Lipid Metabolism in Gestational Diabetes

2 juli 2013 uppdaterad av: Glenn Markenson, Baystate Medical Center

Study of Lipid Metabolism in Gestational Diabetes

The purpose of this pilot study is to determine if, during pregnancy, women with GDM have an exaggerated lipid response compared to non-gestational diabetics. If a difference is noted, further studies will explore the possibility of screening gestational diabetics during their pregnancy for hyperlipidemia to determine if prenatal screening can predict postpartum risk for hyperlipidemia. In addition the relationship, if any between maternal lipid dysfunction and placental disease will be explored.

This will be a prospective cohort study. As part of routine prenatal care, women receive a one hour glucose challenge test to screen for gestational diabetes. Those women with elevated values then require a three hour glucose tolerance test, which is a diagnostic test for gestational diabetes. All women that are scheduled to receive a three hour GTT will be identified and ask to enroll in this study. 46 women whose three hour GTT is normal and thus do not have GDM, will be compared to 46 women with an abnormal three hour GTT and thus would have the diagnosis of GDM. Enrolled women will have a lipid panel consisting of; total cholesterol, triglycerides, HDL and LDL cholesterol at the time of their fasting glucose blood sample. In addition, a repeat lipid panel will be sent at the time of the third hour sample, to assess changes, if any due to the glucose challenge. Umbilical cord blood samples will be sent in order to obtain newborn lipid profiles. Women in both the GDM and normal groups will be asked to return 6-8 weeks

Studieöversikt

Detaljerad beskrivning

The purpose of this pilot study is to determine if, during pregnancy, women with GDM have an exaggerated lipid response compared to non-gestational diabetics. If a difference is noted, further studies will explore the possibility of screening gestational diabetics during their pregnancy for hyperlipidemia to determine if prenatal screening can predict postpartum risk for hyperlipidemia. In addition the relationship, if any between maternal lipid dysfunction and placental disease will be explored. Subsequent studies could also explore the possible perinatal complications associated with elevated lipids and or metabolic syndrome.

C. Experimental Design, Methodology and Expected Results

Study Design:

We propose a prospective cohort design.

Study Population:

All women that are scheduled to receive a three hour GTT to rule out gestational diabetes would be identified and ask to enroll in this study. Specifically, eligible patients will be women who failed their glucose challenge test (GCT) and are scheduled for the follow-up three hour glucose tolerance test (GTT). The GCT is routinely performed among all prenatal care patients at 24-28 wks gestation. The 3 hour GTT requires patients to be fasting overnight. A fasting blood glucose is sampled, and the patients are given a 100 gram glucose drink. Serum glucose samples are then taken at one, two and three hours after the glucose loading. The "exposed" group will be defined as women diagnosed with GDM (elevated glucose values on two or more samples in the three hour GTT). The "unexposed" group will be defined as women with no abnormal glucose values in the three hour GTT.

Studietyp

Observationell

Inskrivning (Faktisk)

106

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Massachusetts
      • Springfield, Massachusetts, Förenta staterna, 01199
        • Baystate Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

16 år till 40 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Pregnant women

Beskrivning

Inclusion Criteria:

  • Pregnancy
  • Abnormal one hour glucose challenge test
  • "Normal" controls group one hour test between 135 mg% and 150 mg%
  • "Gestational diabetic" group with two abnormal values on a 3 hour GTT

Exclusion Criteria:

  • History of diagnosis of diabetes, hypertension, heart disease or chronic renal disease
  • Prior history of lipid disorder or metabolic syndrome
  • Current medications thought to adversely influence glucose tolerance (i.e. prednisone or other steroids and systemic beta-mimetic drugs)
  • Non-singleton pregnancy
  • < 16 years of age or over 40 years of age
  • Not planning to deliver at Baystate Medical Center
  • Twins

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Blivande

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Gestational Diabetics
Patients with Gestational Diabetes
2
Normal pregnant women without gestational diabetes

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Cholesterol
Tidsram: Postpartum
Cholesterol values were obtained at least 6 weeks postpartum from the gestational diabetic group and the normal controls
Postpartum

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Triglyceride Values
Tidsram: Postpartum
Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.
Postpartum
HDL
Tidsram: Postpartum
Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.
Postpartum
LDL
Tidsram: Postpartum
LDL values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.
Postpartum

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Glenn R Markenson, MD, Baystate Medical Center

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2007

Primärt slutförande (Faktisk)

1 november 2010

Avslutad studie (Faktisk)

1 november 2010

Studieregistreringsdatum

Först inskickad

21 september 2007

Först inskickad som uppfyllde QC-kriterierna

21 september 2007

Första postat (Uppskatta)

24 september 2007

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

11 september 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 juli 2013

Senast verifierad

1 juli 2013

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Hyperlipidemi

Kliniska prövningar på Total Cholesterol

3
Prenumerera