Exploring Nutritype Signature of Type 2 Diabetes Risks in Women Post-Gestational Diabetes Mellitus

December 4, 2019 updated by: Barakatun Nisak Bt Mohd Yusof, Universiti Putra Malaysia
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.

Study Overview

Status

Unknown

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Barakatun Nisak Mohd. Yusof, PhD
  • Phone Number: +603-97692606
  • Email: bnisak@upm.edu.my

Study Contact Backup

Study Locations

    • Selangor
      • Serdang, Selangor, Malaysia, 43400
        • Universiti Putra Malaysia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Cross-sectional only
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.
Cross-sectional only
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.
Cross-sectional only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritype signature of T2DM risks in women post-GDM
Time Frame: Through study completion, an average of 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of glucose intolerance
Time Frame: Through study completion, an average of 1 year
To determine prevalence of glucose intolerance (T2DM and pre-diabetes) among women post-GDM
Through study completion, an average of 1 year
Socio-demographic background
Time Frame: Through study completion, an average of 1 year
Difference in socio-demographic background between T2DM, pre-diabetes and non-T2DM groups.
Through study completion, an average of 1 year
Obstetric history
Time Frame: Through study completion, an average of 1 year
Difference in obstetric history between T2DM, pre-diabetes and non-T2DM groups.
Through study completion, an average of 1 year
Nutritional status
Time Frame: Through study completion, an average of 1 year
Difference in nutritional status between T2DM, pre-diabetes and non-T2DM groups.
Through study completion, an average of 1 year
Metabolite profile
Time Frame: Through study completion, an average of 1 year

Difference in metabolite profile between T2DM, pre-diabetes and non-T2DM groups.

Metabolite profile will be analyzed based plasma blood and urine samples, using 1H NMR metabolomics approach.

Through study completion, an average of 1 year
Dietary pattern
Time Frame: Through study completion, an average of 1 year
Difference in dietary pattern between T2DM, pre-diabetes and non-T2DM groups. Dietary pattern will be assessed using Food Frequency Questionnaire.
Through study completion, an average of 1 year
Sleeping pattern
Time Frame: Through study completion, an average of 1 year
Difference in sleeping pattern between T2DM, pre-diabetes and non-T2DM groups. Sleeping pattern will be assessed using a questionnaire.
Through study completion, an average of 1 year
Perceived Stress Scale score
Time Frame: Through study completion, an average of 1 year

Difference in Perceived Stress Scale score between T2DM, pre-diabetes and non-T2DM groups.

PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Minimum score is 10, whereas maximum score is 40.

Through study completion, an average of 1 year
Physical activity level
Time Frame: Through study completion, an average of 1 year
Difference in physical activity level between T2DM, pre-diabetes and non-T2DM groups. Physical activity level will be assessed by International Physical Activity Questionnaire (IPAQ).
Through study completion, an average of 1 year
Smoking habit and exposure
Time Frame: Through study completion, an average of 1 year
Difference in smoking habit and exposure between T2DM, pre-diabetes and non-T2DM groups. Questions on smoking habit and exposure are based on the Global Adult Tobacco Survey.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: 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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2020

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

December 1, 2019

First Submitted That Met QC Criteria

December 4, 2019

First Posted (Actual)

December 9, 2019

Study Record Updates

Last Update Posted (Actual)

December 9, 2019

Last Update Submitted That Met QC Criteria

December 4, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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