The effect of high carbohydrate and low carbohydrate suppers on fasting blood glucose levels (BGLs) in gestational diabetes mellitus (GDM): GDM Supper Study

Not Applicable

Completed

• Conditions: gestational diabetes; Metabolic and Endocrine - Diabetes; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

• Registration Number: ACTRN12617000659303
• Lead Sponsor: Dr Dorothy Graham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-08
• Study Completion: 2020-11-24
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 69

Inclusion Criteria

aHave gestational diabetes diagnosed on routine oral glucose tolerance test. OGTT will diagnose gestational diabetes if fasting BSL is greater than or equal to 5.1, 1 hour reading is greater than or equal to 10, 2 hours greater than or equal to 8.5.
bBe on diet control (no oral hypoglycaemic agents or insulin)
cHave two or more fasting BGLs of 4.7-5.4mmol/L in the week prior to recruitment
dHave a singleton pregnancy
eAre between 24 and 34 weeks gestation
fHave not had hospital admissions or Celestone therapy for the 2 weeks of the study
gHave no food allergies or intolerances that preclude them taking the snack
hAre compliant with BGL monitoring
iFasting BGL recorded between 6am to 8am with a minimum time of 8 hours since their evening snack
jAre capable of giving informed consent
kAre women aged greater than or equal to 18 years of age
lHave dinner between the hours of 5pm and 8 pm, with a 2 hour minimum time between evening meal and evening snack

Exclusion Criteria

aRequiring NovoRapid (fast acting insulin) with meals or requiring Protaphane (long acting insulin) during the two week period (as per treating physician’s decision)
bPatients on metformin or other medications which may affect glucose metabolism (as per treating physician’s decision) during the study
cShift workers, or irregular meal times for any other reason
dgreater than or equal to 3 fasting BGLs greater or equal to 5.2mmol/L in the week prior to recruitment
eMacrosomic foetus, defined as AC greater than 90 percentile or polyhydramnios
fWomen who require an interpreting service
gWomen who have had bariatric surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fasting capillary glucose level as measured with a home glucometer[The outcome is assessed by the participant checking their fasting capillary glucose every day during the 15 day period (each day of the 3 different 5 day intervention periods) of the trial.]

Secondary Outcome Measures

Name	Time	Method
Requirement for insulin as assessed by the physician based on fasting glucose levels, gestation, fetal growth and maternal weight[At the completion of the 15 day intervention or at any timepoint if concern is raised by the participant or treating dietitian regarding the level of their fasting or postprandial glucose levels]