Is Fat in the Liver a Marker of Post-Pregnancy Glycaemic Deterioration in Women With Gestational Diabetes?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- The primary outcome measure for the study will be the mean difference in values of the HOMA-IR (as a surrogate for insulin resistance) in those with NAFLD vs. those without NAFLD 6-12 weeks post partum
研究概览
简要总结
The aim of this study is to utilise ultrasound, using an established method for detecting NAFLD, to determine whether the presence of NAFLD in women with GDM, detected during routine scanning, is a marker of deterioration in glycaemic status post-partum. We propose to assess the relationship between NAFLD and surrogates for insulin resistance as well as glycaemic status, insulin sensitivity and β-cell function, after delivery.
The study is not seeking to compare the incidence of T2DM between those with and without NAFLD. This would require a longer follow-up and larger cohort size. Instead, it aims to quantify the degree of early deterioration of glycaemic status in these groups using insulin resistance markers. This is a clinically important issue as a greater level of insulin resistance would in itself trigger clinical intervention, including vigilant follow-up and empowerment for proactive healthy life style changes, which have been shown to prevent diabetes development .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18 and over
- •Pregnant women diagnosed with GDM based on OGTT
排除标准
- •Women with known type 1 or type 2 diabetes prior to pregnancy
- •Women with known history of liver disease including alcoholic liver disease
- •Women unable or unwilling to consent to be part of the study
- •Women with contraindication to MRI
结局指标
主要结局
The primary outcome measure for the study will be the mean difference in values of the HOMA-IR (as a surrogate for insulin resistance) in those with NAFLD vs. those without NAFLD 6-12 weeks post partum
时间窗: 6-12 weeks post partum
To determine whether the presence of NAFLD during pregnancy in women with gestational diabetes mellitus is a marker of worse metabolic profile (insulin resistance).
次要结局
- Comparison of HbA1c and fasting glucose (standard markers of dysglycaemia) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum(6-12 weeks post partum)
- Comparison of fasting levels from a 4 point OGTT (marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum(6-12 weeks post partum)
- Comparison of Body Mass Index (as part of the Fatty Liver Index) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum(6-12 weeks post partum)
- Comparison of liver function tests (as part of the Fatty Liver Index) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum(6-12 weeks post partum)
- Comparison of disposition index (marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum(6-12 weeks post partum)
- Comparison of area-under-the-curve from 4 point OGTT (marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum(6-12 weeks post partum)
- Comparison of alcohol history in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum(6-12 weeks post partum)
- The presence of fat in the liver using a liver ultrasound scan at baseline and 6-12 weeks post partum.(6-12 weeks post partum)
- MRI scan to confirm the presence of NAFLD at 6-12 weeks post partum.(6-12 weeks post partum)
- Comparison of QUICKI (marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum(6-12 weeks post partum)
- Comparison of insulin and nonesterified fatty acid levels (marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum(6-12 weeks post partum)
- Comparison of ELF blood test results (advanced marker of insulin resistance) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum(6-12 weeks post partum)
- Comparison of waist circumference (as part of the Fatty Liver Index) in those with NAFLD vs. those without NAFLD at 6-12 weeks post partum(6-12 weeks post partum)