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Completed

NCT Number: NCT03378908

Carbohydrates Distribution in Pregnancy Study

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.

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Key information

Conditions

Gestational Diabetes Mellitus in Pregnancy

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Berta Soldevila, Badalona, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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).

Primary outcomes

  1. Preprandial ketonemia

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

    Before the 3 main meals every day.

  2. Glycemic profile below pregnancy target capillary blood glucose concentration

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

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

Secondary outcomes

  1. Area under the curve of interstitial glucose levels

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

    Blinded continuous glucose monitoring data, iPro2, Medtronic (r)): diurnal (from 7 am to 11 pm) and nocturnal (from 11pm to 7 am)

  2. Fetal Macrosomia

    Time frame: Through study completion, 4 weeks

    US assessed fetal weight, adjusted for national standardized charts

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

    Time frame: At delivery

    Large for gestational age > 90th centile, small for gestational age < 10th centile

  4. Newborn hypoglycemia

    Time frame: 48 hours from delivery

    Serum glycemia <40 mg/dL in the first 48 hours of life

  5. Postpartum glucose tolerance of the mother

    Time frame: 6 weeks after delivery

    Plasma glucose levels fasting and 120 minutes after a 75 g oral glucose load

  6. Point-of-care glycated hemoglobin (HbA1c)

    Time frame: Every 2 weeks from the date of randomization until the last visit of the study

    DCA Vantage Analyzer, Siemens ®

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Collaborators

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

Registry information

Official study title

Medical Nutrition Therapy in Gestational Diabetes Mellitus: Comparison of Different Number of Meals. A Pilot Study

Acronym: CHiPS

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 20, 2017
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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