Carbohydrates Distribution in Pregnancy Study

NCT ID: NCT03378908

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2021-09-01

Brief Summary

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Conventional Treatment 6 meals

Diet will be distributed with 6 meals (breakfast, lunch, dinner and 3 snacks). This is the usual diet prescribed for women with GDM at the Department of Endocrinology and Nutrition of both Centers. Energy intake distribution: 25% breakfast, 5% snack, 30% lunch, 10% snack, 25% dinner and 5% snack.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Treatment 3 meals

Diet will be distributed in 3 meals (breakfast, lunch and dinner). Each meal will consist of the addition of the conventional meal and the next snack. Energy intake will be distributed: 30% breakfast (25% breakfast + 5% snack), 40% lunch (30% lunch + 10% snack) and 30% dinner (25% dinner and 5% snack).

Group Type: EXPERIMENTAL

Intervention Treatment

Intervention Type: BEHAVIORAL

Both groups (conventional and treatment) will have the same nutritional composition, with 40% carbohydrates, 20% protein and 40% total fat (preferently monounsaturated fatty acids).

Interventions

Intervention Treatment

Both groups (conventional and treatment) will have the same nutritional composition, with 40% carbohydrates, 20% protein and 40% total fat (preferently monounsaturated fatty acids).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Disability to understand the dietary recommendations and/or to perform self-management of glycemia, ketonuria or ketonemia.
• A low adherence to MNT.
• Problems with write and oral communication.
• Other comorbidities differed of obesity, hypertension and dyslipidemia.
• Insulin criteria within 3 first days of study (fasting glucose ≥90mg/dL, postprandial glucose 1-hour ≥140mg/dL).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Arnau de Vilanova

OTHER

Sponsor Role: collaborator

Institut de Recerca Biomèdica de Lleida

OTHER

Sponsor Role: collaborator

Universitat de Lleida

OTHER

Sponsor Role: collaborator

Fundació Institut Germans Trias i Pujol

OTHER

Sponsor Role: collaborator

Germans Trias i Pujol Hospital

OTHER

Sponsor Role: lead

Responsible Party

Didac Mauricio

Head of Endocrinology and Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Didac Mauricio, MD PHD

Role: STUDY_DIRECTOR

Germans Trias i Pujol Hospital

Locations

Berta Soldevila

Badalona, Barcelona, Spain

Marta Hernández

Lleida, , Spain

Countries

Spain

Other Identifiers

DMG-0001

Identifier Type: -

Identifier Source: org_study_id