Carbohydrates Distribution in Pregnancy Study (CHiPS)

August 3, 2022 updated by: Didac Mauricio, Germans Trias i Pujol Hospital

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Lleida, Spain, 25196
        • Marta Hernández
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Berta Soldevila

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: 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.
Experimental: 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).
Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4 weeks (2 weeks with the conventional treatment and 2 weeks with the intervention treatment)
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
4 weeks (2 weeks with conventional treatment and 2 weeks with intervention treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 4 weeks (2 weeks with conventional treatment and 2 weeks with intervention treatment)
Fetal Macrosomia
Time Frame: Through study completion, 4 weeks
US assessed fetal weight, adjusted for national standardized charts
Through study completion, 4 weeks
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
At delivery
Newborn hypoglycemia
Time Frame: 48 hours from delivery
Serum glycemia <40 mg/dL in the first 48 hours of life
48 hours from delivery
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 weeks after delivery
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 ®
Every 2 weeks from the date of randomization until the last visit of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Germans Trias i Pujol Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Arnau de Vilanova
Fundació Institut Germans Trias i Pujol
Universitat de Lleida
Institut de Recerca Biomèdica de Lleida

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Didac Mauricio, MD PHD, Germans Trias i Pujol Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DMG-0001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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