Gestational Diabetes Mellitus in PregnancyCHiPSNCT03378908
Carbohydrates Distribution in Pregnancy Study
A study testing Intervention Treatment in people with Gestational Diabetes Mellitus in Pregnancy, run by Germans Trias i Pujol Hospital at 2 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- Intervention Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Feb 2018to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Berta Soldevila
Badalona, Barcelona, 08916
Marta Hernández
Lleida, 25196
About this study
Official title: 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.
Read more
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.
- Being tested
- Intervention Treatment
- Keywords
- medical therapy nutrition, meal, carbohydrates, intervention, food intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention TreatmentBehavioural
Both groups (conventional and treatment) will have the same nutritional composition, with 40% carbohydrates, 20% protein and 40% total fat (preferently monounsaturated fatty acids).
| Study group | Role | What they receive |
|---|---|---|
| Conventional Treatment 6 meals | No intervention | 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. |
| Intervention Treatment 3 meals | Experimental | 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). Receives: Behavioral: Intervention Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preprandial ketonemia
Before the 3 main meals every day.
Measured: 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
Measured: 4 weeks (2 weeks with conventional treatment and 2 weeks with intervention treatment)
Secondary outcomes (6)
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)
Measured: 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
Measured: 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
Measured: At delivery
Newborn hypoglycemia
Serum glycemia <40 mg/dL in the first 48 hours of life
Measured: 48 hours from delivery
Postpartum glucose tolerance of the mother
Plasma glucose levels fasting and 120 minutes after a 75 g oral glucose load
Measured: 6 weeks after delivery
Point-of-care glycated hemoglobin (HbA1c)
DCA Vantage Analyzer, Siemens ®
Measured: Every 2 weeks from the date of randomization until the last visit of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start1 Feb 2018
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Arnau de Vilanova, Institut de Recerca Biomèdica de Lleida, Universitat de Lleida, Fundació Institut Germans Trias i Pujol
- Responsible party
- Principal investigator, Didac Mauricio, Germans Trias i Pujol Hospital
- Investigators
- Didac Mauricio, MD PHD, Study director, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378908
- Sponsor's protocol ID
- DMG-0001
- Acronym
- CHiPS
- Status last verified
- Aug 2022
- First submitted
- 4 Dec 2017
- Last updated
- 4 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Nutrition Therapy in Gestational Diabetes Mellitus: Comparison of Different Number of Meals. A Pilot Study
- ClinicalTrials.gov ID
- NCT03378908
- Acronym / sponsor ID
- CHiPS / DMG-0001
- Keywords
- medical therapy nutrition, meal, carbohydrates, intervention, food intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Collaborators
- Hospital Arnau de Vilanova, Institut de Recerca Biomèdica de Lleida, Universitat de Lleida, Fundació Institut Germans Trias i Pujol
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 20 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Treatment 6 meals | No intervention | –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. |
| Intervention Treatment 3 meals | Experimental | Behavioral: Intervention TreatmentDiet 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). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women with GDM diagnosed in 24-28 weeks.
- Age 18-40 years.
- Pregnancy age of 28-32 weeks.
- Caucasian.
- Body mass index ≤ 35Kg/m2.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention TreatmentBoth groups (conventional and treatment) will have the same nutritional composition, with 40% carbohydrates, 20% protein and 40% total fat (preferently monounsaturated fatty acids). | Behavioural | Intervention Treatment 3 meals |
Primary outcome
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.
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
6 secondary outcomes
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)
Fetal Macrosomia
Time frame: Through study completion, 4 weeks
Newborn body weight adjusted for gestational age (national standardized charts)
Time frame: At delivery
Newborn hypoglycemia
Time frame: 48 hours from delivery
Postpartum glucose tolerance of the mother
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
Related trials for Gestational Diabetes Mellitus in Pregnancy
Recruiting
Fueling Labor: Protein Supplementation for Intrapartum Glucose Control
Diabetes During Pregnancy
Not yet recruiting
A Randomized Trial to Reduce Blood Pressure at One Year Postpartum After Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Recruiting
RIGHTEST iFree 2 CGM in Pregnant Women With Diabetes Study
Diabetes Mellitus, Type 1 Diabetes, Diabetes Mellitus, Type 2
Not yet recruiting
The WAIT Trial: Waiting Versus Active Induction at Term in Women With A1 Gestational Diabetes Mellitus
Gestational Diabetes Mellitus (GDM)
Recruiting
Effects Of Core Canister Training in Pregnant Women With History of Gestational Diabetes Mellitus
Antenatal Care Model, Gestatiaonl Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didac Mauricio, MD PHD study director
Germans Trias i Pujol Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Treatment in people with Gestational Diabetes Mellitus in Pregnancy, run by Germans Trias i Pujol Hospital at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preprandial ketonemia (time frame: 4 weeks (2 weeks with the conventional treatment and 2 weeks with the intervention treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.