Carbohydrates Distribution in Pregnancy Study

NCT03378908 | Completed

• 1 other identifier: DMG-0001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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

Keywords

medical therapy nutrition; meal; carbohydrates; intervention; food intake

Outcome Measures

Primary Outcomes (2)

• Preprandial ketonemia

  Before the 3 main meals every day.

  4 weeks (2 weeks with the conventional treatment and 2 weeks with the intervention treatment)

• Glycemic profile below pregnancy target capillary blood glucose concentration

  Self monitoring blood glucose levels: pre meals \< 90 mg/dL, 1 hour post meals \<140mg/dL

  4 weeks (2 weeks with conventional treatment and 2 weeks with intervention treatment)

Secondary Outcomes (6)

• Area under the curve of interstitial glucose levels

  Time Frame: 4 weeks (2 weeks with conventional treatment and 2 weeks with intervention treatment)

• Fetal Macrosomia

  Through study completion, 4 weeks

• Newborn body weight adjusted for gestational age (national standardized charts)

  At delivery

• Newborn hypoglycemia

  48 hours from delivery

• Postpartum glucose tolerance of the mother

  6 weeks after delivery

Study Arms (2)

Conventional Treatment 6 meals

NO INTERVENTION

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.

Intervention Treatment 3 meals

EXPERIMENTAL

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).

Behavioral: Intervention Treatment

Interventions

Intervention Treatment 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).

Intervention Treatment 3 meals

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead
• Hospital Arnau de Vilanova: collaborator
• Institut de Recerca Biomèdica de Lleida: collaborator
• Universitat de Lleida: collaborator
• Fundació Institut Germans Trias i Pujol: collaborator

Study Sites (2)

Berta Soldevila

Badalona, Barcelona, 08916, Spain

Location

Marta Hernández

Lleida, 25196, Spain

Location

MeSH Terms

Interventions

Crisis Intervention

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Didac Mauricio, MD PHD

  Germans Trias i Pujol Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Glycemic profile will be collected with a blind-sensor during the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Endocrinology and Nutrition

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 20, 2017
• Study Start: February 1, 2018
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: August 4, 2022

Record last verified: 2022-08

Locations

ES (2)