Exploring Nutritype Signature of Type 2 Diabetes Risks in Women Post-Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Nutritype signature of T2DM risks in women post-GDM
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Nutritype signature of T2DM risks in women post-GDM
时间窗: 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.
次要结局
- Perceived Stress Scale score(Through study completion, an average of 1 year)
- Physical activity level(Through study completion, an average of 1 year)
- 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)
- Dietary pattern(Through study completion, an average of 1 year)
- Sleeping pattern(Through study completion, an average of 1 year)
- Smoking habit and exposure(Through study completion, an average of 1 year)
研究者
Barakatun Nisak Bt Mohd Yusof
Associate Professor
Universiti Putra Malaysia