Manchester Intermittent Diet in Gestational Diabetes Acceptability Study (MIDDAS-GDM)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05344066 |
Recruitment Status :
Active, not recruiting
First Posted : April 25, 2022
Last Update Posted : May 3, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gestational Diabetes Gestational Diabetes Mellitus in Pregnancy Intermittent Fasting Pregnancy Related Diabetes Diabetes in Pregnancy | Other: Best NHS Care Other: Intermittent Low Energy Diet | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomised two-arm feasibility trial |
Masking: | None (Open Label) |
Masking Description: | Non blinded (statistician and laboratory staff will remain blinded). |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | November 24, 2022 |
Estimated Primary Completion Date : | July 31, 2024 |
Estimated Study Completion Date : | July 31, 2024 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Best NHS Care
Best National Health Service (NHS) Care
|
Other: Best NHS Care
Personalised advice and support from a diabetes dietician to follow NICE healthy eating diet and physical activity recommendations for GDM. |
Experimental: Intermittent Low Energy Diet
Intermittent Low Energy Diet
|
Other: Intermittent Low Energy Diet
Two non-consecutive days of a food based 1000 kcal diet and five days of the NICE healthy eating diet and physical activity recommendations for the best NHS care group. |
- Trial recruitment rate [ Time Frame: 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.
- Retention to the trial [ Time Frame: Duration of trial (68 weeks) ]Retention rate will be measured as the percentage of participants who complete all scheduled 8 visits.
- Trial uptake [ Time Frame: Duration of trial (68 weeks) ]Trial uptake will be measured as the percentage of eligible participants who consent to participate in the trial.
- Adherence to the interventional intermittent low-calorie diet over course of study [ Time Frame: 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.
- Adherence to capillary glucose and ketone measurements over course of study [ Time Frame: 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 hypoglycaemia requiring intervention [ Time Frame: 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.
- Episodes of ketonaemia requiring intervention [ Time Frame: 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 [ Time Frame: 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 neonatal hypoglycaemia [ Time Frame: 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.
- Neonatal birthweight [ Time Frame: At delivery ]Neonatal birth weight will be measured in kilograms and recorded in both groups.
- Neonatal gestational age at delivery [ Time Frame: At delivery ]Gestational age at delivery will be measured in weeks and recorded in both groups.
- Gestational age at delivery [ Time Frame: At delivery ]Gestational age at delivery in weeks will be recorded in both groups.
- Rates of admission to special care baby unit or neonatal intensive care [ Time Frame: 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.
- Number of stillbirths [ Time Frame: At delivery ]Number of stillbirths will be recorded in both groups.
- Number of completed scheduled patient contacts [ Time Frame: Duration of trial (68 weeks) ]Completion of scheduled patient contacts with the trial dietitian and gestational diabetes midwife will be recorded and compared between groups.
- Completion rates of food diaries [ Time Frame: 4 day food diaries at 24-30 weeks' gestation, 34-35 weeks' gestation, 36-37 weeks' gestation, and 12-13 weeks postpartum. ]Participants will be asked to complete 4-day food diaries for 4 weeks of the trial at 24-28 weeks' gestation, 34-35 weeks' gestation, 36-37 weeks' gestation, and 12-13 weeks postpartum. They will also be given the option of recording diaries during the other weeks as this may help with their adherence. Completion rates of the food diaries each week across the whole intervention as a percentage of weeks in both groups will inform the utility of food diaries for tracking diet behaviour in both groups
- Completion rates of International Physical Activity Questionnaire (IPAQ) [ Time Frame: IPAQ questionnaire at 24-30 weeks' gestation, 34-35 weeks' gestation, 36-37 weeks' gestation, and 12-13 weeks postpartum. ]Participants will be asked to complete the IPAQ during 4 weeks of the trial at 24-28 weeks' gestation, 34-35 weeks' gestation, 36-37 weeks' gestation, and 12-13 weeks postpartum. Completion rates will be measured as a percentage of weeks completed in both groups.
- The acceptability of the dietary interventions will be explored qualitatively [ Time Frame: 12-13 weeks' postpartum ]A subset of participants in both groups (approximately 5 participants from each group) will be invited to an optional qualitative substudy which will involve one semi-structured interview at the end of the intervention. Participants will be asked about their experiences and thoughts regarding the intervention. Key themes will be identified using Braun and Clarke's thematic analysis to identify key issues around the acceptability of the test intervention.
- Percentage of participants commencing metformin [ Time Frame: From 24-30 weeks' gestation until delivery. ]The percentage of women commencing metformin will be measured.
- Percentage of participants commencing insulin [ Time Frame: From 24-30 weeks' gestation until delivery. ]The percentage of women commencing insulin will be measured.
- Changes in HbA1c (mmol/mol) [ Time Frame: Recorded at 24-30 weeks' gestation, 36-37 weeks' gestation, and at 12-13 weeks postpartum ]Bloods will be taken at 27-29 weeks' gestation, 36-37 weeks' gestation, and at 12-13 weeks postpartum. Changes in HbA1c between these time points will be compared within and between groups and expressed in mmol/mol.
- Changes in fasting glucose (mmol/L) [ Time Frame: Recorded at 24-30 weeks' gestation, 36-37 weeks' gestation, and at 12-13 weeks postpartum ]Bloods will be taken at 27-29 weeks' gestation, 36-37 weeks' gestation, and at 12-13 weeks postpartum. Changes in fasting glucose between these time points will be compared within and between groups and expressed in mmol/L.
- Changes in fasting insulin (mU/L) [ Time Frame: Recorded at 24-30 weeks' gestation, 36-37 weeks' gestation, and at 12-13 weeks postpartum ]Bloods will be taken at 27-29 weeks' gestation, 36-37 weeks' gestation, and at 12-13 weeks postpartum. Changes in insulin levels between these time points within and between groups will be compared and expressed in mU/L.
- Oral Glucose Tolerance Test (mmol/L) result [ Time Frame: 11-13 weeks' postpartum ]Oral Glucose Tolerance Test (OGTT) will be completed at 11-13 weeks postpartum. Fasting and 2 hour postprandial bloods will be measured and the percentage of women with a diagnosis of residual diabetes according to the World Health Organization (WHO) criteria will be reported in both groups.
- Changes in the value of Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) [ Time Frame: Recorded at 24-30 weeks' gestation, 36-37 weeks' gestation, and at 12-13 weeks postpartum ]HOMA-IR will be calculated from fasting glucose and insulin measurements [(fasting insulin mU/L x fasting glucose nmol/L)/22.5] assessed at 27-29 weeks' gestation, 36-37 weeks' gestation, and at 12-13 weeks postpartum. Changes in HOMA-IR between these time points will be compared within and between groups.
- Changes in maternal health status [ Time Frame: Recorded at 24-30 weeks' gestation, 31-33 weeks' gestation, 36-37 weeks' gestation, and at 12-13 weeks postpartum ]Health status (SF-36) questionnaires will be completed in both groups and scores compared both within and between groups. Scores range from 1-100; the lower the score the more the disability, the higher the score the more favourable the health state.
- Changes in maternal quality of life [ Time Frame: Recorded at 24-30 weeks' gestation, 31-33 weeks' gestation, 36-37 weeks' gestation, and at 12-13 weeks postpartum ]Quality of life (WHOQoL-BREF) questionnaires will be completed in both groups and scores compared both within and between groups. This questionnaire measures four domains (physical health, psychological, social relationships and environment). Final scores range between 1-100; higher scores indicate a higher quality of life.
- Changes in maternal glycaemic control [ Time Frame: From 24-30 weeks' gestation until delivery ]Four-point capillary glucose profiles (four times daily) between 27-29 weeks' gestation and delivery will be compared within and between groups. The percentage of women within target ranges will be reported within and between groups (fasting <5.3 and 1 hour postprandial <7.8 mmol/l).
- Mode of delivery [ Time Frame: At delivery ]Mode of delivery will be recorded in both groups
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05344066
United Kingdom | |
Manchester University NHS Foundation trust | |
Manchester, United Kingdom, M13 9WU |
Principal Investigator: | Basil Issa | Manchester Foundation Trust |
Responsible Party: | Manchester University NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT05344066 |
Other Study ID Numbers: |
B01410 |
First Posted: | April 25, 2022 Key Record Dates |
Last Update Posted: | May 3, 2024 |
Last Verified: | December 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Patient identifiable data will not be shared. Anonymised trial data will be available on reasonable request to the investigators. |
Time Frame: | Data will be available following data analysis and publication, and will be accessible for 5-10 years. |
Access Criteria: | To be confirmed |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Diabetes, Gestational Pregnancy in Diabetics Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |