Carbohydrates Distribution in Pregnancy Study (CHiPS)

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: Completed
• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Intervention / Treatment: Behavioral: Intervention Treatment

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve of interstitial glucose levels	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	US assessed fetal weight, adjusted for national standardized charts	Through study completion, 4 weeks
Newborn body weight adjusted for gestational age (national standardized charts)	Large for gestational age > 90th centile, small for gestational age < 10th centile	At delivery
Newborn hypoglycemia	Serum glycemia <40 mg/dL in the first 48 hours of life	48 hours from delivery
Postpartum glucose tolerance of the mother	Plasma glucose levels fasting and 120 minutes after a 75 g oral glucose load	6 weeks after delivery
Point-of-care glycated hemoglobin (HbA1c)	DCA Vantage Analyzer, Siemens ®	Every 2 weeks from the date of randomization until the last visit of the study

Collaborators and Investigators

• Sponsor: Germans Trias i Pujol Hospital
• Collaborators: Hospital Arnau de Vilanova; Fundació Institut Germans Trias i Pujol; Universitat de Lleida; Institut de Recerca Biomèdica de Lleida
• Investigators: Study Director: Didac Mauricio, MD PHD, Germans Trias i Pujol Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: December 4, 2017
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (Actual): December 20, 2017

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: intervention; carbohydrates; food intake; medical therapy nutrition; meal
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID 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