Carbohydrates Distribution in Pregnancy Study

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

— CHiPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03378908
• Other study ID #: DMG-0001
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: September 1, 2021

Study information

• Verified date: August 2022
• Source: Germans Trias i Pujol Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics

Intervention

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).

Locations

Country	Name	City	State
Spain	Berta Soldevila	Badalona	Barcelona
Spain	Marta Hernández	Lleida

Sponsors (5)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital	Fundació Institut Germans Trias i Pujol, Hospital Arnau de Vilanova, Institut de Recerca Biomèdica de Lleida, Universitat de Lleida

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preprandial ketonemia	Before the 3 main meals every day.	4 weeks (2 weeks with the conventional treatment and 2 weeks with the intervention treatment)
Primary	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	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)
Secondary	Fetal Macrosomia	US assessed fetal weight, adjusted for national standardized charts	Through study completion, 4 weeks
Secondary	Newborn body weight adjusted for gestational age (national standardized charts)	Large for gestational age > 90th centile, small for gestational age < 10th centile	At delivery
Secondary	Newborn hypoglycemia	Serum glycemia <40 mg/dL in the first 48 hours of life	48 hours from delivery
Secondary	Postpartum glucose tolerance of the mother	Plasma glucose levels fasting and 120 minutes after a 75 g oral glucose load	6 weeks after delivery
Secondary	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