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Study examining the effects of altering a diet's macronutrient composition on plasma ketone levels in women with gestational diabetes mellitus

A Randomised controlled trial (RCT) examining the effects of a modestly lower carbohydrate diet on plasma ketone levels in women with gestational diabetes mellitus (GDM)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000018415
Acronym
MAMI GDM (Macronutrient Adjustments in Mothers to Improve Gestational Diabetes Mellitus)
Enrollment
45
Registered
2016-01-14
Start date
2016-04-07
Completion date
2018-03-15
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To our knowledge no study investigated serum ketone levels in Gestational Diabetes Mellitus (GDM) pregnancy with a modestly lower carbohydrate diet. Our primary aim is to document a range of blood ketone in women on a routine GDM diet (180-200 g carbohydrates/day) and a modestly lower carbohydrate diet (135g carbohydrates/day). The 135 g of carbohydrate/day is an absolute amount of carbohydrate which is in line with Institute of Medicine (IOM) recommendation for carbohydrate intake during pregnancy. We also aim to examine the effect of modestly lower carbohydrate diet on the risk of ketonemia in GDM pregnancy. We hypothesise that when compared to a routine GDM diet, a modestly lower carbohydrate diet will not increase ketone levels in GDM pregnancy, nor will it increase the risk of adverse pregnancy outcomes including risk of large/small gestational age babies and caesarean delivery. If our hypotheses are proven to be correct, perhaps prescribing a modestly lower carbohydrate diet to no less than 135g/day will be the new standard for treatment of GDM.

Interventions

Arm 1 Intervention - Main focus will be limiting daily carbohydrate intake to 135 g. Carbohydrates should be spread evenly through out the day, with 2 carbohydrate exchanges per main meal (3 times a day) and 1 exchange per mid meal (also 3 times a day). One exchange equals to consuming 15 g of carbohydrate and this proves to be a useful method of monitoring carbohydrate intake, particularly in individuals diagnosed with diabetes. A research dietitian will have ongoing contact with participants v

Arm 1 Intervention - Main focus will be limiting daily carbohydrate intake to 135 g. Carbohydrates should be spread evenly through out the day, with 2 carbohydrate exchanges per main meal (3 times a day) and 1 exchange per mid meal (also 3 times a day). One exchange equals to consuming 15 g of carbohydrate and this proves to be a useful method of monitoring carbohydrate intake, particularly in individuals diagnosed with diabetes. A research dietitian will have ongoing contact with participants via phone (to arrange meetings) and during 4 face-to-face sessions (including a baseline and 3 other follow up visits in Week 2, Week 4 and Week 6, all lasting no more than an hour). To prevent study bias, participants will be unaware of their group allocation. They will, however, receive a pictorial booklet containing acceptable carbohydrate portions of various foods. The study dietitian will also verbally guide participants on the acceptable amount and distribution of carbohydrates . A 3-day food record will be collected at baseline and in the last (6th or 7th) week of the study, where as a 24 hour recall will be conducted at 2 follow up visits to confirm diet compliance. Non-compliant participants will be re-educated. Food packages including breads, cereals, pasta and rice will be handed to women to help model portion size (i.e. what represents 1 exchange) and enhance participation rate. The study is designed to last 6-7weeks (though 6 ideally), but this will depend on participant's availability and ability to attend all the face-to-face sessions.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

1. Women diagnosed with gestational diabetes mellitus (GDM) at 24-30 weeks gestation 2. Singleton pregnancy 3. Age between 18-45 years

Exclusion criteria

1. Women with special dietary requirements (e.g. vegan/vegetarian, gluten free) 2. Existence of co-morbidities other than obesity, hypertension or dyslipidemia 3. Pre-existing diabetes 4. Undesirable lifestyle habits such as smoking and alcohol consumption 5. Pregnancy achieved by assisted reproduction (IVF)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 26, 2026