Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-29 @ 2:58 AM
Study NCT ID:
NCT05344066
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2022-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Manchester Intermittent Diet in Gestational Diabetes Acceptability Study
Sponsor:
Manchester University NHS Foundation Trust
Organization:
Study Overview
Official Title:
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIDDAS-GDM
Brief Summary:
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.
Detailed Description:
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.
Primary Objectives:
* Uptake rate
* Recruitment rate
* Retention rate
* Adherence to the dietary interventions
* Completion of self-assessed glucose and ketone readings
Safety outcomes:
* Percentage of women following ILED/best NHS care with hypoglycaemia (episodes of blood glucose of \<3.0mmol/mol)
* Percentage of women who develop significant ketonaemia in both groups (defined as ≥1.0mmol/L)
* Percentage of neonatal hypoglycaemic episodes requiring intervention, neonatal birth weight, gestational age at delivery, hyperbilirubinaemia/jaundice, and/or admission to Special Care Baby Unit or neonatal intensive care, and stillbirths
* The incidence and rate of other adverse events (e.g. headaches, lethargy, constipation, or complications requiring hospital admission) between the start of the trial intervention and delivery.
Secondary outcomes
* Completeness of collection of trial endpoints
* Fidelity of delivery of the interventions
* Qualitative analysis of the acceptability and implementation of the interventions
Exploratory outcomes The following outcomes will be explored without statistical inference.
1. Maternal outcomes:
* The percentage of women requiring metformin and/or insulin
* Four-point capillary glucose profiles during third trimester
* Change in fasting blood test results between baseline measurements, 36-37 weeks' gestation, and 12 weeks post-delivery
* Mode of delivery, development of preeclampsia, polyhydramnios (maximum liquor volume pool depth ≥8 cm)
* Quality of life and health status questionnaires (WHOQoL-BREF and SF-36 questionnaires)
2. Foetal outcomes:
* Foetal weight
* Gestational age at delivery
Method:
We aim to recruit 48 women with GDM diagnosed between 24-30 weeks gestation from antenatal clinics at Wythenshawe and St Mary's hospitals, Manchester Foundation Trust, over 13 months starting in November 2022. Participants will be randomised (1:1) to ILED (2 low-energy diet days/week of 1000kcal and 5 days/week of the best NHS care healthy diet and physical activity advice) or best NHS care 7 days/week until delivery of their baby. Primary outcomes include uptake and retention of participants to the trial, and adherence to both dietary interventions. Safety outcomes will include birthweight, gestational age at delivery, neonatal hypoglycaemic episodes requiring intervention, neonatal hyperbilirubinaemia, admission to special care baby unit or neonatal intensive care unit, stillbirths, the percentage of women with hypoglycaemic episodes requiring third-party assistance, and significant maternal ketonaemia (defined as ≥1.0mmol/L) Secondary outcomes will assess the fidelity of delivery of the interventions, and qualitative analysis of participant and healthcare professionals' experiences of the diet. Exploratory outcomes include the number of women requiring metformin and/or insulin.
Qualitative evaluation:
Investigators will undertake qualitative analysis of the experiences and thoughts of approximately 5 participants per group and healthcare professionals delivering the interventions.
Anticipated impact and dissemination:
This study will inform the feasibility and design of a definitive RCT of ILED versus best NHS care in GDM. Findings will be disseminated to health professionals and patients through published articles, conference presentations and patient networks in collaboration with the patient and public involvement and engagement panel.
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.
Primary Objectives:
* Uptake rate
* Recruitment rate
* Retention rate
* Adherence to the dietary interventions
* Completion of self-assessed glucose and ketone readings
Safety outcomes:
* Percentage of women following ILED/best NHS care with hypoglycaemia (episodes of blood glucose of \<3.0mmol/mol)
* Percentage of women who develop significant ketonaemia in both groups (defined as ≥1.0mmol/L)
* Percentage of neonatal hypoglycaemic episodes requiring intervention, neonatal birth weight, gestational age at delivery, hyperbilirubinaemia/jaundice, and/or admission to Special Care Baby Unit or neonatal intensive care, and stillbirths
* The incidence and rate of other adverse events (e.g. headaches, lethargy, constipation, or complications requiring hospital admission) between the start of the trial intervention and delivery.
Secondary outcomes
* Completeness of collection of trial endpoints
* Fidelity of delivery of the interventions
* Qualitative analysis of the acceptability and implementation of the interventions
Exploratory outcomes The following outcomes will be explored without statistical inference.
1. Maternal outcomes:
* The percentage of women requiring metformin and/or insulin
* Four-point capillary glucose profiles during third trimester
* Change in fasting blood test results between baseline measurements, 36-37 weeks' gestation, and 12 weeks post-delivery
* Mode of delivery, development of preeclampsia, polyhydramnios (maximum liquor volume pool depth ≥8 cm)
* Quality of life and health status questionnaires (WHOQoL-BREF and SF-36 questionnaires)
2. Foetal outcomes:
* Foetal weight
* Gestational age at delivery
Method:
We aim to recruit 48 women with GDM diagnosed between 24-30 weeks gestation from antenatal clinics at Wythenshawe and St Mary's hospitals, Manchester Foundation Trust, over 13 months starting in November 2022. Participants will be randomised (1:1) to ILED (2 low-energy diet days/week of 1000kcal and 5 days/week of the best NHS care healthy diet and physical activity advice) or best NHS care 7 days/week until delivery of their baby. Primary outcomes include uptake and retention of participants to the trial, and adherence to both dietary interventions. Safety outcomes will include birthweight, gestational age at delivery, neonatal hypoglycaemic episodes requiring intervention, neonatal hyperbilirubinaemia, admission to special care baby unit or neonatal intensive care unit, stillbirths, the percentage of women with hypoglycaemic episodes requiring third-party assistance, and significant maternal ketonaemia (defined as ≥1.0mmol/L) Secondary outcomes will assess the fidelity of delivery of the interventions, and qualitative analysis of participant and healthcare professionals' experiences of the diet. Exploratory outcomes include the number of women requiring metformin and/or insulin.
Qualitative evaluation:
Investigators will undertake qualitative analysis of the experiences and thoughts of approximately 5 participants per group and healthcare professionals delivering the interventions.
Anticipated impact and dissemination:
This study will inform the feasibility and design of a definitive RCT of ILED versus best NHS care in GDM. Findings will be disseminated to health professionals and patients through published articles, conference presentations and patient networks in collaboration with the patient and public involvement and engagement panel.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: