MIDDAS-GDM: A Two-Arm Randomised Feasibility Protocol Trial of an Intermittent Low-Energy Diet (ILED) in Women With Gestational Diabetes and Obesity in Greater Manchester
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Trial uptake
研究概览
简要总结
A two-arm non-blinded randomised feasibility protocol trial designed to assess the feasibility, safety, and acceptability of an intermittent low energy diet (ILED) vs best National Health Service (NHS) care in women with gestational diabetes and obesity in Greater Manchester.
详细描述
Overall aim:
The aim of this trial is to test the safety, feasibility, and acceptability of an ILED in GDM to inform a future large-scale RCT.
Background:
Up to 16% of pregnant women in the United Kingdom develop GDM with rising rates due to increasing rates of obesity and maternal age. GDM affects both maternal and neonatal outcomes and is a high burden to patients and the NHS through frequent clinic visits, monitoring, and costly medications such as insulin. The National Institute for Health and Care Excellence (NICE) guidelines advocate healthy diet (with increased physical activity [PA]) as first-line therapy for GDM with approximately 30% progressing to metformin and/or insulin treatment. Our Patient and Public Involvement and Engagement work demonstrates that women with GDM are keen for alternative dietary interventions to reduce their need for medications. It has been shown that intermittent low energy diets improve glycaemic control in type-2 diabetes. The investigators wish to test the utility of ILED in GDM.
Primary Aim: to test the safety, feasibility, and acceptability of an ILED in GDM to inform a future large-scale RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Non blinded (statistician and laboratory staff will remain blinded).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women ≥18 years
- •BMI of ≥27.5kg/m2 or a BMI ≥25 kg/m2 in high risk minority ethnic group (i.e. South Asian, Black African, African Caribbean) and <50 kg/m2 at booking appointment (8-12 weeks' gestation)
- •Newly diagnosed GDM according to local diagnostic criteria (fasting glucose ≥5.3mmol/l and/or 2-hour postprandial glucose ≥8.5mmol/l in a 75g OGTT) scheduled to receive first line diet and physical activity (best NHS care)
- •24-30 weeks pregnant at screening appointment
排除标准
- •Pregestational type 1 or type 2 diabetes.
- •Fasting glucose of ≥7 or 2-hour postprandial of ≥11 on OGTT (immediate intervention with medication would be required in this group of women)
- •Current multiple pregnancy
- •Maturity Onset Diabetes of the Young (MODY)
- •Significant comorbid disease that in PI's opinion would preclude participation in the study e.g. chronic kidney disease, significant cardiac disease, history of disordered eating or severe psychological problems.
- •Current participation in a GDM medication treatment trial
- •People who are not capable of providing informed consent or adhering to the monitoring and safety protocols
- •People who have previously had bariatric surgery for weight loss including gastric bypass and sleeve gastrectomy, and/or those prescribed weight loss medications (e.g. orlistat).
- •Medications at the time of the OGTT that may interfere with results (e.g. high dose oral steroids, immunosuppressants)
- •Previous history of intrauterine growth restriction
- •Women who have lost more than 5% of their weight from booking appointment to screening appointment.
结局指标
主要结局
Trial uptake
时间窗: Duration of trial (68 weeks)
Trial uptake will be measured as the percentage of eligible participants who consent to participate in the trial.
Rates of neonatal hypoglycaemia
时间窗: From delivery until 12 hours post-delivery
Percentage of neonatal hypoglycaemic episodes requiring intervention (blood glucose checked 2-hours post delivery and 2-hours thereafter for 12 hours) will be recorded in both groups.
Trial recruitment rate
时间窗: Duration of trial (68 weeks)
Uptake to trial will be measured as a percentage of eligible participants who consent to participate in the trial per month.
Adherence to capillary glucose and ketone measurements over course of study
时间窗: From randomisation (at 24-30 weeks' gestation) to delivery
The number of self-assessed glucose (4 times a day) and ketone (3 times a day on two days of the week) measurements in both groups over the course of the study.
Episodes of ketonaemia requiring intervention
时间窗: From 24-30 weeks' gestation until delivery.
The percentage of women with self-reported significant ketonaemia (capillary ketones \>1 mmol/l) will be measured and compared between groups.
Rates of neonatal hyperbilirubinaemia/jaundice
时间窗: From delivery until final visit at 12-13 weeks' postpartum
Percentage of neonatal hyperbilirubinaemia/jaundice (defined as a total serum bilirubin level above 86 μmol/l) episodes will be recorded in both groups.
Rates of admission to special care baby unit or neonatal intensive care
时间窗: From delivery until final visit at 12-13 weeks' postpartum
Rates of admission to Special Care Baby Unit or Neonatal Intensive Care will be recorded in both groups.
Adherence to the interventional intermittent low-calorie diet over course of study
时间窗: From randomisation (at 24-30 weeks' gestation) to delivery.
Self-reported adherence to the two potential low-calorie days per week expressed as a percentage of the potential low-calorie days in the intermittent low energy diet group.
Retention to the trial
时间窗: Duration of trial (68 weeks)
Retention rate will be measured as the percentage of participants who complete all scheduled 8 visits.
Episodes of hypoglycaemia requiring intervention
时间窗: From 24-30 weeks' gestation until delivery.
The percentage of women with self-reported hypoglycaemia (capillary blood glucose of \<3.0 mmol/l) will be measured and compared between groups.
Neonatal birthweight
时间窗: At delivery
Neonatal birth weight will be measured in kilograms and recorded in both groups.
Neonatal gestational age at delivery
时间窗: At delivery
Gestational age at delivery will be measured in weeks and recorded in both groups.
Gestational age at delivery
时间窗: At delivery
Gestational age at delivery in weeks will be recorded in both groups.
Number of stillbirths
时间窗: At delivery
Number of stillbirths will be recorded in both groups.
次要结局
- Number of completed scheduled patient contacts(Duration of trial (68 weeks))
- Completion rates of food diaries(4 day food diaries at 24-30 weeks' gestation, 34-35 weeks' gestation, 36-37 weeks' gestation, and 12-13 weeks postpartum.)
- Completion rates of International Physical Activity Questionnaire (IPAQ)(IPAQ questionnaire at 24-30 weeks' gestation, 34-35 weeks' gestation, 36-37 weeks' gestation, and 12-13 weeks postpartum.)
- The acceptability of the dietary interventions will be explored qualitatively(12-13 weeks' postpartum)