Maternal Hypertriglyceridaemia Study

NCT02479113 | Unknown DMC

• 1 other identifier: 201401-0691
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome X

Keywords

GDM; Maternal Hypertriglyceridaemia

Outcome Measures

Primary Outcomes (1)

• Relationship between maternal pregravid BMI/ Tg/NEFA/HOMA2%-S and BW/neonatal adiposity

  3 years

Secondary Outcomes (10)

• Neonatal fatty liver on ultrasound/fetal insulin secretion/fetal insulin resistance

  3 years

• Neonatal hypoglycaemia in GDM offspring weighing > 3.5 kg

  6 years

• Neonatal adiposity in GDM offspring weighing > 3.5 kg

  6 years

• Macrosomia in women with with pregravid BMI >23 kg/m2

  6 years

• Maternal and fetal outcomes in GDM group on diet compared with insulin

  6 years

Study Arms (3)

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

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

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

Interventions

Blood sampling PROCEDURE

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; Lean with normal glucose tolerance; Obese with Normal glucose tolerance

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \>18 years of age
• Malaysian Indian Chinese or Malay descent
• singleton pregnancy
• gestation 12- 32 weeks

You may not qualify if:

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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University of Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

RECRUITING

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

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Shireene Vethakkan, MD

  University of Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shireene Vethakkan, MD

CONTACT

shireene.vethakkan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: June 24, 2015
• Study Start: March 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2024
• Last Updated: November 1, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)