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Trial record 7 of 95 for:    body | Recruiting, Not yet recruiting, Available Studies | "Metabolic Syndrome X"

Maternal Hypertriglyceridaemia Study

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ClinicalTrials.gov Identifier: NCT02479113
Recruitment Status : Recruiting
First Posted : June 24, 2015
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
University of Malaya

Brief Summary:
Besides maternal hyperglycemia, a strong link between maternal pregravid weight/maternal triglyceride(Tg) levels and fetal growth/childhood obesity/metabolic syndrome in offspring has been demonstrated in largely Caucasian populations. This study aims to explore the link between maternal hypertriglyceridemia and offspring health in Asians.

Condition or disease Intervention/treatment
Metabolic Syndrome X Procedure: Blood sampling

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pregravid Body Mass Index (BMI), Maternal Hypertriglyceridemia During Pregnancy and Body Composition/Metabolic Health of Asian GDM Offspring
Study Start Date : March 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2024


Group/Cohort Intervention/treatment
Lean with normal glucose tolerance

Pregnant women who are lean with normal glucose tolerance

- Bloods will be taken at 12 - 32 weeks, at 36 weeks/ delivery

Procedure: Blood sampling
At 12 - 32 weeks: All patients need blood sampling for OGTT + insulin + C-peptide + fasting triglyceride + NEFA At 36 weeks/ delivery: All patients need blood sampling for fasting glucose + insulin + C-peptide + fasting triglyceride + NEFA At 36 weeks/ delivery: only GDM patients need blood sampling for HbA1c + fructosamine

Obese with Normal glucose tolerance

Pregnant women who are obese with normal glucose tolerance

- Bloods will be taken at 12 - 32 weeks, at 36 weeks/ delivery

Procedure: Blood sampling
At 12 - 32 weeks: All patients need blood sampling for OGTT + insulin + C-peptide + fasting triglyceride + NEFA At 36 weeks/ delivery: All patients need blood sampling for fasting glucose + insulin + C-peptide + fasting triglyceride + NEFA At 36 weeks/ delivery: only GDM patients need blood sampling for HbA1c + fructosamine

Gestational diabetes mellitus

Pregnant women who have Gestational Diabetes Mellitus

- Bloods will be taken at 12 - 32 weeks, at 36 weeks/ delivery

Procedure: Blood sampling
At 12 - 32 weeks: All patients need blood sampling for OGTT + insulin + C-peptide + fasting triglyceride + NEFA At 36 weeks/ delivery: All patients need blood sampling for fasting glucose + insulin + C-peptide + fasting triglyceride + NEFA At 36 weeks/ delivery: only GDM patients need blood sampling for HbA1c + fructosamine




Primary Outcome Measures :
  1. Relationship between maternal pregravid BMI/ Tg/NEFA/HOMA2%-S and BW/neonatal adiposity [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Neonatal fatty liver on ultrasound/fetal insulin secretion/fetal insulin resistance [ Time Frame: 3 years ]
  2. Neonatal hypoglycaemia in GDM offspring weighing > 3.5 kg [ Time Frame: 6 years ]
  3. Neonatal adiposity in GDM offspring weighing > 3.5 kg [ Time Frame: 6 years ]
  4. Macrosomia in women with with pregravid BMI >23 kg/m2 [ Time Frame: 6 years ]
  5. Maternal and fetal outcomes in GDM group on diet compared with insulin [ Time Frame: 6 years ]
  6. Neonatal body composition in GDM group on diet compared with insulin [ Time Frame: 6 years ]
  7. Offspring metabolic characteristics in highest and lowest maternal Tg quintile quintile [ Time Frame: 10 years ]
  8. DNA methylation of placental leptin gene [ Time Frame: 10 years ]
  9. Cord blood miRNA 29 [ Time Frame: 6 years ]
  10. Incidence of Pre-eclampsia [ Time Frame: 6 years ]

Biospecimen Retention:   Samples With DNA
Placental tissue for epigenetic studies of the leptin gene, and cord blood for leptin and micro RNA29 (miR29) will be collected


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

This study is implemented in 2 phases.

In Phase 1 , N=400, pregnant women (lean with NGT 150, obese with NGT 100, GDM 150) of Asian descent will be recruited from the UMMC Antenatal Clinic.

In Phase 2, the offspring of 150 GDM mothers, 40 lean NGT controls and 40 obese NGT mothers from Phase 1 form a cohort that will continue to be followed up at intervals (6 months, 1 year, 3 years, 5 years, 7 years and 10 years) till age 10 years with evaluation of body composition, growth, pubertal development and metabolic health. Equal numbers of girls and boys will be recruited. Data will be collected on breastfeeding practices and diet/physical activity.

Criteria

Inclusion Criteria:

  1. >18 years of age
  2. Malaysian Indian Chinese or Malay descent
  3. singleton pregnancy
  4. gestation 12- 32 weeks

Exclusion Criteria:

  1. Multiple pregnancy
  2. Assisted conception
  3. pregestational type 1 or type 2 diabetes
  4. endocrine disorders that affect weight/insulin resistance i.e. hypo- or hyper-thyroidism, Cushing's syndrome , acromegaly and phaeochromocytoma
  5. overt diabetes diagnosed during pregnancy(FPG >7.0/ A1c >6.5%/ RPG> 11.1)
  6. Smokers
  7. Chronic systemic disease
  8. Infection(HIV/Hepatitis B/C, TB, TORCHES)
  9. diseases requiring treatment with exogenous steroids such as bronchial asthma, SLE, rheumatoid arthritis
  10. Fetal anomalies
  11. IUGR
  12. premature delivery (<37 weeks by clinical assessment or ultrasound) likely because of maternal disease other than GDM/PIH
  13. significant meconium or fetal distress on cardiotocography at delivery
  14. Infants unable to undergo assessment of body composition within 48 hrs of birth

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02479113


Contacts
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Contact: Shireene Vethakkan, MD shireene.vethakkan@gmail.com

Locations
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Malaysia
University of Malaya Recruiting
Kuala Lumpur, Malaysia, 50603
Contact: Shireene Vethakkan, MD       shireene.vethakkan@gmail.com   
Sub-Investigator: Noor Azmi B Mat Adenan, MBChB         
Sub-Investigator: Muhammad Yazid B Jalaludin, MBBS         
Sub-Investigator: Lee Ling Lim, MRCP (UK)         
Sponsors and Collaborators
University of Malaya
Investigators
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Principal Investigator: Shireene Vethakkan, MD University of Malaya

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Responsible Party: University of Malaya
ClinicalTrials.gov Identifier: NCT02479113     History of Changes
Other Study ID Numbers: 201401-0691
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Malaya:
GDM
Maternal Hypertriglyceridaemia

Additional relevant MeSH terms:
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Metabolic Syndrome
Hypertriglyceridemia
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders