Clinical trial NCT04190199: Exploring Nutritype Signature of Type 2 Diabetes Risks in Women Post-Gestational Diabetes Mellitus
Official title: Exploring Nutritype Signature of Type 2 Diabetes Risks in Women Post-Gestational Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes
Gestational Diabetes
Keywords: Metabolomic
Nutritype
Dietary Pattern
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Malaysia
name: Universiti Teknologi Mara
First posted: 2019-12-09
Enrollment: 270
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_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.

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.

Detailed description: Women with a history of gestational diabetes mellitus (GDM) or post-GDM are at high risk of developing type 2 diabetes (T2DM). This is important in the present context because T2DM has reached epidemic proportions. In Malaysia, the prevalence of T2DM has increased by almost 80% in just over a 10 year period. Current recommendation supports early screening at 6 weeks postpartum via oral glucose tolerance testing (OGTT) after GDM. However, the screening of women after GDM remains suboptimal, with a very low compliance rate up to almost 20%. Also, none of the recommendations highlights the need of having nutrition screening assessments despite the fact that nutritional stimuli are highly relevant to expedite disease progression in women post-GDM.

As such, the metabolomics technique can be used as a tool to measure the full profile of small-molecule metabolites in bio-fluids. This technique has been expanded beyond biological disciplines towards nutrition research leading to the emerging concept of Nutritype. Nutritype refers to the expression of overall dietary intake in metabolites; work that capable to classify individuals into a certain dietary pattern based on the metabolomics profiles. While the role of metabolomics is significance, no exploration of the Nutritype signatures has been established.

Potential significant determinants for the progression from GDM to T2DM include genetics, factors during the index pregnancy, exogenous modifiable risk factors and factors specific to intermediate biological mechanisms with no data on metabolites profile. Although the metabolomic signatures predicting GDM transition to T2DM in women post-GDM have been identified, its metabolites related to a protective dietary pattern is unknown.

This concept is timely needed as the objective assessment of dietary intake is a huge challenge that lacks biological validation. Although several biomarkers of foods exist, identification of metabolites signature that reflects overall dietary patterns is scarce. While a healthful dietary pattern such as the alternate Healthy Eating Index (aHEI) reduces the risk of T2DM among women post-GDM, none of the patterns tailored to Malaysian diet. Direct extrapolation of these findings to the overall Malaysian diet is unknown.

Therefore, the study aims to discover and identify the Nutritype signatures which combine information on dietary pattern biomarkers and metabolites profiles of T2DM risk in women post-GDM using metabolomics approach. The data will then be used to identify a predictive model of Nutritype signatures to develop protective dietary pattern works according to individuals' metabolite in preventing T2DM among women post-GDM. The findings aid in establishing an early measure of T2DM prevention in women post-GDM based on the metabolite profile that reflects the overall diet. This new exciting work leads to the goal of achieving precision diabetes-nutrition prevention using a multi-pronged strategy.

This is a cross-sectional comparative study involving women post-GDM. Women with a history of GDM will have their nutritional status, metabolite profile, dietary pattern and lifestyle practices assessed. They will undergo Oral Glucose Tolerance Test (OGTT) to determine T2DM diagnosis, based on Clinical Practice Guidelines Malaysia. Based on their OGTT results, they will be divided into 3 groups: T2DM, prediabetes (impaired fasting glucose \[IFG\] or impaired glucose tolerance \[IGT\]), or non-T2DM.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria

* 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.

Primary outcomes:
measure: Nutritype signature of T2DM risks in women post-GDM
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Prevalence of glucose intolerance
timeFrame: Through study completion, an average of 1 year
measure: Socio-demographic background
timeFrame: Through study completion, an average of 1 year
measure: Obstetric history
timeFrame: Through study completion, an average of 1 year
measure: Nutritional status
timeFrame: Through study completion, an average of 1 year
measure: Metabolite profile
timeFrame: Through study completion, an average of 1 year
measure: Dietary pattern
timeFrame: Through study completion, an average of 1 year
measure: Sleeping pattern
timeFrame: Through study completion, an average of 1 year
measure: Perceived Stress Scale score
timeFrame: Through study completion, an average of 1 year
measure: Physical activity level
timeFrame: Through study completion, an average of 1 year
measure: Smoking habit and exposure
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: Universiti Putra Malaysia
state: Selangor
Study officials:
affiliation: Universiti Putra Malaysia
name: Barakatun Nisak Mohd. Yusof, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Putra Malaysia
name: Farah Yasmin Hasbullah, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Putra Malaysia
name: Geeta Appannah, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Teknologi Mara (UiTM)
name: Rohana Abdul Ghani, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Putra Malaysia
name: Zulfitri 'Azuan Mat Daud, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Medical University (IMU)
name: Winnie Chee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.