NCT03378908: CHiPS

Carbohydrates Distribution in Pregnancy Study

Completed NA Last updated 4 August 2022

What this trial tests

NA trial testing Intervention Treatment in Gestational Diabetes Mellitus in Pregnancy in 10 participants. Completed in 1 September 2021.

Timeline

1 February 2018

Primary endpoint
1 September 2021

1 September 2021

Quick facts

Lead sponsor	Germans Trias i Pujol Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	supportive care
Enrollment	10
Start date	1 February 2018
Primary completion	1 September 2021
Estimated completion	1 September 2021
Sites	2 locations across Spain

Drugs / interventions tested

• Intervention Treatment

Conditions studied

• Gestational Diabetes Mellitus in Pregnancy — all drugs for Gestational Diabetes Mellitus in Pregnancy →

Sponsor

Germans Trias i Pujol Hospital

Who can join

Adults 18 to 40, female only, with Gestational Diabetes Mellitus in Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hypothesis: Patients with Gestational Diabetes Mellitus (GDM) have a high risk to develop complications during pregnancy, puerperium and in the newborn. At present there are not scientific evidences about the optimal distribution of meals in the medical nutrition therapy (MNT) and their relationship with glycemic control.

Aim: To explore and compare ketonemia and glycemic profile in patients with GDM that follow a MNT distributed in 6 or 3 meals. Besides, we want to explore the differences between both treatments in glucose dynamics.

Methods: The study design is a randomized, crossover and multicentric trial. A sample of 10 patients with GDM will be recruited in the Department of Endocrinology and Nutrition from both centres. In a randomized manner patients will follow the conventional treatment (a carbohydrate-controlled diet distributed in 6 meals: 3 main meals and 3 snacks) and the intervention treatment (a carbohydrate-controlled diet distributed in 3 meals: breakfast, lunch and dinner). They will be randomized to begin with one of the two treatments, and after two weeks they will be switched to the other treatment. Patients will wear a blinded continuous glucose monitoring device (iPro2-TM, Medtronic) during the entire study period.

Inclusion criteria:

* Women with GDM diagnosed in 24-28 weeks.
* Age 18-40 years.
* Pregnancy age of 28-32 weeks.
* Caucasian.
* Body mass index ≤ 35 Kg/m2.

Exclusion criteria:

* Unability to understand the dietary recommendations and/or to perform self-management of glycemia, ketonuria or ketonemia.
* A low adherence to MNT.
* Problems with written and/or oral communication.
* Presence of comorbidities other than obesity, hypertension and dyslipidemia.
* Insulin-need criteria within 3 first days of the beginning of the study (fasting glucose ≥90mg/dL, postprandial glucose 1-hour ≥140mg/dL).

Clinical and sociodemographic variables will be assessed. Dietary records and blood samples will be collected. Daily basal ketonuria and ketonemia before each meal will be assessed. Glycemic profile will be collected with a blind-sensor during the four weeks of the intervention study. Generalized linear model analysis will be performed. Statistical power will be 80% and significance level will be set at 0.05. Written informed consent will be collected from all participants.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.