NCT05344066

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

November 24, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

May 3, 2024

Status Verified

December 1, 2023

Enrollment Period

1.7 years

First QC Date

February 11, 2022

Last Update Submit

May 2, 2024

Conditions

Gestational DiabetesGestational Diabetes Mellitus in PregnancyIntermittent FastingPregnancy RelatedDiabetesDiabetes in Pregnancy

Outcome Measures

Primary Outcomes (14)

  • Trial recruitment rate

    Uptake to trial will be measured as a percentage of eligible participants who consent to participate in the trial per month.

    Duration of trial (68 weeks)

  • Retention to the trial

    Retention rate will be measured as the percentage of participants who complete all scheduled 8 visits.

    Duration of trial (68 weeks)

  • Trial uptake

    Trial uptake will be measured as the percentage of eligible participants who consent to participate in the trial.

    Duration of trial (68 weeks)

  • Adherence to the interventional intermittent low-calorie diet over course of study

    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.

    From randomisation (at 24-30 weeks' gestation) to delivery.

  • Adherence to capillary glucose and ketone measurements over course of study

    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.

    From randomisation (at 24-30 weeks' gestation) to delivery

  • Episodes of hypoglycaemia requiring intervention

    The percentage of women with self-reported hypoglycaemia (capillary blood glucose of \<3.0 mmol/l) will be measured and compared between groups.

    From 24-30 weeks' gestation until delivery.

  • Episodes of ketonaemia requiring intervention

    The percentage of women with self-reported significant ketonaemia (capillary ketones \>1 mmol/l) will be measured and compared between groups.

    From 24-30 weeks' gestation until delivery.

  • Rates of neonatal hyperbilirubinaemia/jaundice

    Percentage of neonatal hyperbilirubinaemia/jaundice (defined as a total serum bilirubin level above 86 μmol/l) episodes will be recorded in both groups.

    From delivery until final visit at 12-13 weeks' postpartum

  • Rates of neonatal hypoglycaemia

    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.

    From delivery until 12 hours post-delivery

  • Neonatal birthweight

    Neonatal birth weight will be measured in kilograms and recorded in both groups.

    At delivery

  • Neonatal gestational age at delivery

    Gestational age at delivery will be measured in weeks and recorded in both groups.

    At delivery

  • Gestational age at delivery

    Gestational age at delivery in weeks will be recorded in both groups.

    At delivery

  • Rates of admission to special care baby unit or neonatal intensive care

    Rates of admission to Special Care Baby Unit or Neonatal Intensive Care will be recorded in both groups.

    From delivery until final visit at 12-13 weeks' postpartum

  • Number of stillbirths

    Number of stillbirths will be recorded in both groups.

    At delivery

Secondary Outcomes (4)

  • 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

Other Outcomes (11)

  • Percentage of participants commencing metformin

    From 24-30 weeks' gestation until delivery.

  • Percentage of participants commencing insulin

    From 24-30 weeks' gestation until delivery.

  • Changes in HbA1c (mmol/mol)

    Recorded at 24-30 weeks' gestation, 36-37 weeks' gestation, and at 12-13 weeks postpartum

  • +8 more other outcomes

Study Arms (2)

Best NHS Care

ACTIVE COMPARATOR

Best National Health Service (NHS) Care

Other: Best NHS Care

Intermittent Low Energy Diet

EXPERIMENTAL

Intermittent Low Energy Diet

Other: Intermittent Low Energy Diet

Interventions

Best NHS CareOTHER

Personalised advice and support from a diabetes dietician to follow NICE healthy eating diet and physical activity recommendations for GDM.

Best NHS Care
Intermittent Low Energy DietOTHER

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.

Intermittent Low Energy Diet

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • weeks pregnant at screening appointment

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manchester University NHS Foundation trust

Manchester, M13 9WU, United Kingdom

Location

Related Publications (1)

  • Dapre E, Issa BG, Harvie M, Su TL, McMillan B, Pilkington A, Hanna F, Vyas A, Mackie S, Yates J, Evans B, Mubita W, Lombardelli C. Manchester Intermittent Diet in Gestational Diabetes Acceptability Study (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. BMJ Open. 2024 Feb 10;14(2):e078264. doi: 10.1136/bmjopen-2023-078264.

    PMID: 38341207DERIVED

MeSH Terms

Conditions

Diabetes, GestationalIntermittent FastingDiabetes Mellitus

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesFastingFeeding BehaviorBehavior

Study Officials

  • Basil Issa

    Manchester Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Non blinded (statistician and laboratory staff will remain blinded).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised two-arm feasibility trial
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2022

First Posted

April 25, 2022

Study Start

November 24, 2022

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

May 3, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

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

Locations

GB(1)