NCT04190199

Brief Summary

Women post-gestational diabetes mellitus (GDM) have more than 7-fold increased risk of having future type 2 diabetes mellitus (T2DM). While a healthful dietary pattern reduces the risk of diabetes in post-GDM, no data support a dietary pattern tailored to the Malaysian diet. To address this issue, the investigators propose to determine the effects of dietary patterns and plasma metabolites in predicting the risk of T2DM known as the Nutritype model. The aim of this study is to identify Nutritype signatures of T2DM risk in women post-GDM using metabolomics approach.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 1, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

December 9, 2019

Status Verified

December 1, 2019

Enrollment Period

1 year

First QC Date

December 1, 2019

Last Update Submit

December 4, 2019

Conditions

Type 2 DiabetesGestational Diabetes

Keywords

MetabolomicNutritypeDietary Pattern

Outcome Measures

Primary Outcomes (1)

  • Nutritype signature of T2DM risks in women post-GDM

    To identify the nutritype signatures of T2DM risks in women post-GDM using proton nuclear magnetic resonance (1H NMR) based metabolomics approach.

    Through study completion, an average of 1 year

Secondary Outcomes (10)

  • Prevalence of glucose intolerance

    Through study completion, an average of 1 year

  • Socio-demographic background

    Through study completion, an average of 1 year

  • Obstetric history

    Through study completion, an average of 1 year

  • Nutritional status

    Through study completion, an average of 1 year

  • Metabolite profile

    Through study completion, an average of 1 year

  • +5 more secondary outcomes

Study Arms (3)

Type 2 diabetes mellitus (T2DM)

Subjects in this group are diagnosed with type 2 diabetes mellitus. They receive no intervention. Their nutritional status, metabolite profile, dietary pattern, and lifestyle practices will be assessed.

Other: Observational

Pre-diabetes (IFG or IGT)

Subjects in this group are diagnosed with pre-diabetes (impaired fasting glucose \[IFG\] or impaired glucose tolerance \[IGT\]). They receive no intervention. Their nutritional status, metabolite profile, dietary pattern, and lifestyle practices will be assessed.

Other: Observational

Non-type 2 diabetes mellitus (healthy)

Subjects in this group are not diagnosed with type 2 diabetes mellitus or pre-diabetes (healthy). They receive no intervention. Their nutritional status, metabolite profile, dietary pattern, and lifestyle practices will be assessed.

Other: Observational

Interventions

ObservationalOTHER

Cross-sectional only

Non-type 2 diabetes mellitus (healthy)Pre-diabetes (IFG or IGT)Type 2 diabetes mellitus (T2DM)

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women with previous GDM will be screened for inclusion and exclusion criteria. Those eligible will be asked to come to the clinic for the further ascertainment of the current status of T2DM by undergoing oral glucose tolerance test (OGTT) based on the criteria set by CPG DM (2015). Based on this diagnostic criteria, they will be divided into 3 groups: either T2DM, pre-diabetes (IFG/IGT), or non-T2DM.

You may qualify if:

  • Malaysian women at childbearing age of 18-50 years old
  • Have a history of GDM
  • Women with known case of impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) with or without medications

You may not qualify if:

  • Pregnant women
  • Those with prior history of type 1 or type 2 diabetes
  • Recent hospitalization (within 6 weeks)
  • Presence of reported or previously diagnosed medical conditions
  • Receiving drugs (such as steroids and weight-reducing agents)
  • Have a significant weight loss of 10% from original body weight within 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Putra Malaysia

Serdang, Selangor, 43400, Malaysia

Location

Related Publications (10)

  • Allalou A, Nalla A, Prentice KJ, Liu Y, Zhang M, Dai FF, Ning X, Osborne LR, Cox BJ, Gunderson EP, Wheeler MB. A Predictive Metabolic Signature for the Transition From Gestational Diabetes Mellitus to Type 2 Diabetes. Diabetes. 2016 Sep;65(9):2529-39. doi: 10.2337/db15-1720. Epub 2016 Jun 23.

    PMID: 27338739BACKGROUND

  • Bhupathiraju SN, Hu FB. One (small) step towards precision nutrition by use of metabolomics. Lancet Diabetes Endocrinol. 2017 Mar;5(3):154-155. doi: 10.1016/S2213-8587(17)30007-4. Epub 2017 Jan 13. No abstract available.

    PMID: 28089710BACKGROUND

  • Institute for Public Health [IPH]. 2015. Vol. II: Non-communicable diseases, risk factors and other health problems. National Health and Morbidity Survey (NHMS 2015). Kuala Lumpur, Malaysia: IPH, Ministry of Health.

    BACKGROUND

  • Malaysian Endocrine & Metabolic Society [MEMS] and Ministry of Health [MOH] Malaysia. 2015. Management of type 2 diabetes mellitus (5th Edition). Kuala Lumpur, Malaysia: MEMS & MOH.

    BACKGROUND

  • Nielsen KK, Kapur A, Damm P, de Courten M, Bygbjerg IC. From screening to postpartum follow-up - the determinants and barriers for gestational diabetes mellitus (GDM) services, a systematic review. BMC Pregnancy Childbirth. 2014 Jan 22;14:41. doi: 10.1186/1471-2393-14-41.

    PMID: 24450389BACKGROUND

  • O'Gorman A, Brennan L. The role of metabolomics in determination of new dietary biomarkers. Proc Nutr Soc. 2017 Aug;76(3):295-302. doi: 10.1017/S0029665116002974. Epub 2017 Jan 16.

    PMID: 28091346BACKGROUND

  • Tee ES, Yap RWK. Type 2 diabetes mellitus in Malaysia: current trends and risk factors. Eur J Clin Nutr. 2017 Jul;71(7):844-849. doi: 10.1038/ejcn.2017.44. Epub 2017 May 17.

    PMID: 28513624BACKGROUND

  • Tobias DK, Hu FB, Chavarro J, Rosner B, Mozaffarian D, Zhang C. Healthful dietary patterns and type 2 diabetes mellitus risk among women with a history of gestational diabetes mellitus. Arch Intern Med. 2012 Nov 12;172(20):1566-72. doi: 10.1001/archinternmed.2012.3747.

    PMID: 22987062BACKGROUND

  • Zhang C, Hu FB, Olsen SF, Vaag A, Gore-Langton R, Chavarro JE, Bao W, Yeung E, Bowers K, Grunnet LG, Sherman S, Kiely M, Strom M, Hansen S, Liu A, Mills J, Fan R; DWH study team. Rationale, design, and method of the Diabetes & Women's Health study--a study of long-term health implications of glucose intolerance in pregnancy and their determinants. Acta Obstet Gynecol Scand. 2014 Nov;93(11):1123-30. doi: 10.1111/aogs.12425. Epub 2014 Jun 9.

    PMID: 24828694BACKGROUND

  • Kim C, Newton KM, Knopp RH. Gestational diabetes and the incidence of type 2 diabetes: a systematic review. Diabetes Care. 2002 Oct;25(10):1862-8. doi: 10.2337/diacare.25.10.1862.

    PMID: 12351492BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma blood and urine

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes, Gestational

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Barakatun Nisak Mohd. Yusof, PhD

    Universiti Putra Malaysia

    PRINCIPAL INVESTIGATOR

  • Farah Yasmin Hasbullah, MSc

    Universiti Putra Malaysia

    PRINCIPAL INVESTIGATOR

  • Geeta Appannah, PhD

    Universiti Putra Malaysia

    PRINCIPAL INVESTIGATOR

  • Rohana Abdul Ghani, PhD

    Universiti Teknologi Mara (UiTM)

    PRINCIPAL INVESTIGATOR

  • Zulfitri 'Azuan Mat Daud, PhD

    Universiti Putra Malaysia

    PRINCIPAL INVESTIGATOR

  • Winnie Chee, PhD

    International Medical University (IMU)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barakatun Nisak Mohd. Yusof, PhD

CONTACT

+603-97692606bnisak@upm.edu.my

Farah Yasmin Hasbullah, MSc

CONTACT

+60123235874farahyasmin90@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 1, 2019

First Posted

December 9, 2019

Study Start

May 1, 2020

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

December 9, 2019

Record last verified: 2019-12

Locations

MY(1)