Ignite Creation Date:
2024-05-06 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03378908
Status:
COMPLETED
Last Update Posted:
2022-08-04
First Post:
2017-12-04
Brief Title:
Carbohydrates Distribution in Pregnancy Study
Sponsor:
Germans Trias i Pujol Hospital
Organization:
Germans Trias i Pujol Hospital
Study Overview
Official Title:
Medical Nutrition Therapy in Gestational Diabetes Mellitus Comparison of Different Number of Meals A Pilot Study
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHiPS
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 Kgm2
Exclusion criteria
Unability to understand the dietary recommendations andor to perform self-management of glycemia ketonuria or ketonemia
A low adherence to MNT
Problems with written andor 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 90mgdL postprandial glucose 1-hour 140mgdL
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 005 Written informed consent will be collected from all participants
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 Kgm2
Exclusion criteria
Unability to understand the dietary recommendations andor to perform self-management of glycemia ketonuria or ketonemia
A low adherence to MNT
Problems with written andor 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 90mgdL postprandial glucose 1-hour 140mgdL
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 005 Written informed consent will be collected from all participants
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None