Diabetes, GestationalNCT03835208
Effect of Carbohydrate Distribution on Blood Glucose in Women With Gestational Diabetes Mellitus (GDM)
A study testing High/low carbohydrate distribution in people with Diabetes, Gestational, run by University of Aarhus at 2 sites in Denmark.
Trial summary
This study aims to investigate whether high-morning carbohydrate intake (HMK) compared with low-morning carbohydrate intake (LMK) affects glycemic variability in GDM patients based on Continuous glucose monitoring (CGM). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetes, Gestational
- What is being tested?
- High/low carbohydrate distribution
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesDenmark
- Study dates
- 25 Feb 2019to 1 May 2020
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gestational diabetes mellitus diagnosed according to current WHO criteria for a 2-hour oral glucose tolerance test (OGTT) > 8.5 mmol/l
- Non-insulin depending
- Adult 18+ years
- Gestational age weeks 30-36 at start of inclusion
Who cannot join
- Diagnosed with celiac disease
- Received bariatric surgery
- Diagnosed eating disorder
- Insulin-dependent diabetes at trial start
- Known with type 2 diabetes before pregnancy
- Children under 18 years
Show all 9Show fewer
- Starting up in insulin during the intervention period
- Diagnosed with lactose intolerance
- Goes into labor before the intervention is completed
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
University hospital Aarhus
Skejby, Aarhus N, 8200
University of Aarhus
Skejby, Aarhus N, 8200
About this study
Official title: The Effect of High-morning-carbohydrate Intake Versus Low-morning-carbohydrate Intake on Glycemic Variability Measured by Continuous Glucose Monitoring in GDM Patients - a Randomized Crossover Study
This study aims to investigate whether high-morning carbohydrate intake (HMK) compared with low-morning carbohydrate intake (LMK) affects glycemic variability in GDM patients based on Continuous glucose monitoring (CGM).
High carbohydrate morning intake is expected to reduce hyperglycemic episodes and stabilize blood glucose compared with low morning carbohydrate intake.
Read the detailed description
Background:
Women with GDM have an increased risk of macrosomia, cesarean section, birth defects and long term complications such as an increased risk, in both mother and child, to develop type 2 diabetes.
According to Invitro and invivo studies of type 1 and 2 diabetes, great variations in blood glucose levels caused more complications than constantly elevated glucose levels. This study, therefore, intends to use Continuous glucose monitoring (CGM) for day-to-day monitoring of glycemic variability, including frequency, duration, and magnitude of hyperglycaemic fluctuations.
Carbohydrate is the macronutrient that has the greatest impact on postprandial blood glucose response. Despite this, there is a current lack of evidence of how the carbohydrate intake should be distributed throughout a day.
This study aims to investigate whether high-morning carbohydrate intake (HMK) compared to low-morning carbohydrate intake (LMK) affects glycemic variability in GDM patients.
Design:
Randomized crossover intervention study comparing two intervention diets; high-morning carbohydrate intake (HMK) versus low-morning carbohydrate intake (LMK) each of 3 days duration with four-day washout.
Diet intervention: Both intervention diets have the same calorie content and contain the same amounts of protein, carbohydrate and fat for the individual patient, but the distribution of carbohydrate and energy differs throughout the day.
Dietary intake will be estimated through 24-hour recall interview by trained dietitians. Estimation of actual intake is validated by photos of every main meal.
All data will be collected and stored in RedCap to secure data checks.
Statistics Analysis and sample size:
Power calculation on primary outcome MAGE- estimates 15 patients for inclusion with a power of 80%, SD 0,6mmol/l, a significance level of 0,05 and a MIREDIF of 0,5 mmol/l. 15 persons include an expected dropout rate at 20%.
Non-parametric tests will be used for the secondary and primary outcome.
Perspective:
A future perspective of this study is to improve the current treatment in regards to nutritional recommendations. Thus, the study could potentially contribute with the knowledge that would clarify the carbohydrate recommendations and improve the glycemic control of patients with GDM and therefore be beneficial to patients' future treatment and prevent complications and development of type 2 diabetes in the child.
- Conditions
- Diabetes, Gestational
- Being tested
- High/low carbohydrate distribution
- Keywords
- gestational diabetes, carbohydrate distribution, high/low carbohydrate, glycemic variability, MAGE, continuous glucose monitoring, Pregnancy in Diabetics
- Medical subject headings
- Diabetes, Gestational, Pregnancy in Diabetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High/low carbohydrate distributionBehavioural
Also called High-energy breakfasting compared with high-energy dinner
A total of 2x3 days, were the patient follow a detailed diet plan. For 3 days they follow a diet plan where the majority of the carbohydrates are located on either the first part of the day(HMK) or the last part of the day(LMK). 4 days of washout are placed between the two interventions. They will not receive food but will be guided by a trained dietitian and the use of a meal plan.
| Study group | Role | What they receive |
|---|---|---|
| Low-morning-carbohydrate | Experimental | Low morning intake and high evening intake of carbohydrates. This means a distribution of carbohydrate as follows:
10% morning, 40% lunch, 50% dinner. The overall recommendations for macro- and micronutrient intake for GDM patients will be met. Receives: Behavioral: High/low carbohydrate distribution |
| High-morning-carbohydrate | Experimental | High morning intake and low evening intake of carbohydrates.
This means a distribution of carbohydrate as follows:
50% morning, 40% lunch, 10% dinner. The overall recommendations for macro- and micronutrient intake for GDM patients will be met. Receives: Behavioral: High/low carbohydrate distribution |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean amplitude of glucose excursions (MAGE)
An index for glycemic variability assessment MAGE is the average variation in amplitude and is calculated as the mean of absolute value differences between adjacent glucose peaks and valleys, where the differences exceed 1 Standard Deviation (SD) from the mean.
Measured: 6 days
Secondary outcomes (5)
Coefficient of variation
Coefficient of variation
Measured: 6 days
MBG
The average blood glucose, calculated for each two intervention periods using CGM data.
Measured: 6 days
Glucagon-like-peptide 1 (GLP1)
glucagon-like-peptide 1, difference in 1 hour postprandial response
Measured: 1 hour *2
Gastric inhibitory polypeptide (GIP)
Gastric inhibitory polypeptide difference in 1 hour postprandial response
Measured: 1 hour*2
C-peptide
Changes in C-peptide according to carbohydrate distribution
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start25 Feb 2019
- Primary completion27 Sep 2019
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, GestationalStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each patient will follow the HMK and LMK diet in a period of 2x3 days in randomized order with a four day washout between. The order of the two diets will be assigned randomly.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor
- Investigators
- Per G Ovesen, Dr.Med, Study director, Women's diseases and births
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835208
- Sponsor's protocol ID
- HMKvLMK
- Status last verified
- Jul 2019
- First submitted
- 7 Feb 2019
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High-morning-carbohydrate Intake Versus Low-morning-carbohydrate Intake on Glycemic Variability Measured by Continuous Glucose Monitoring in GDM Patients - a Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT03835208
- Acronym / sponsor ID
- HMKvLMK
- Conditions
- Diabetes, Gestational
- Keywords
- gestational diabetes, carbohydrate distribution, high/low carbohydrate, glycemic variability, MAGE, continuous glucose monitoring, Pregnancy in Diabetics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 27 Sep 2019 (actual)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 8 Feb 2019 (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.
This study aims to investigate whether high-morning carbohydrate intake (HMK) compared with low-morning carbohydrate intake (LMK) affects glycemic variability in GDM patients based on Continuous glucose monitoring (CGM).
High carbohydrate morning intake is expected to reduce hyperglycemic episodes and stabilize blood glucose compared with low morning carbohydrate intake.
Detailed description
Background:
Women with GDM have an increased risk of macrosomia, cesarean section, birth defects and long term complications such as an increased risk, in both mother and child, to develop type 2 diabetes.
According to Invitro and invivo studies of type 1 and 2 diabetes, great variations in blood glucose levels caused more complications than constantly elevated glucose levels. This study, therefore, intends to use Continuous glucose monitoring (CGM) for day-to-day monitoring of glycemic variability, including frequency, duration, and magnitude of hyperglycaemic fluctuations.
Carbohydrate is the macronutrient that has the greatest impact on postprandial blood glucose response. Despite this, there is a current lack of evidence of how the carbohydrate intake should be distributed throughout a day.
This study aims to investigate whether high-morning carbohydrate intake (HMK) compared to low-morning carbohydrate intake (LMK) affects glycemic variability in GDM patients.
Design:
Randomized crossover intervention study comparing two intervention diets; high-morning carbohydrate intake (HMK) versus low-morning carbohydrate intake (LMK) each of 3 days duration with four-day washout.
Diet intervention: Both intervention diets have the same calorie content and contain the same amounts of protein, carbohydrate and fat for the individual patient, but the distribution of carbohydrate and energy differs throughout the day.
Dietary intake will be estimated through 24-hour recall interview by trained dietitians. Estimation of actual intake is validated by photos of every main meal.
All data will be collected and stored in RedCap to secure data checks.
Statistics Analysis and sample size:
Power calculation on primary outcome MAGE- estimates 15 patients for inclusion with a power of 80%, SD 0,6mmol/l, a significance level of 0,05 and a MIREDIF of 0,5 mmol/l. 15 persons include an expected dropout rate at 20%.
Non-parametric tests will be used for the secondary and primary outcome.
Perspective:
A future perspective of this study is to improve the current treatment in regards to nutritional recommendations. Thus, the study could potentially contribute with the knowledge that would clarify the carbohydrate recommendations and improve the glycemic control of patients with GDM and therefore be beneficial to patients' future treatment and prevent complications and development of type 2 diabetes in the child.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each patient will follow the HMK and LMK diet in a period of 2x3 days in randomized order with a four day washout between. The order of the two diets will be assigned randomly.
| Arm | Type | Receives |
|---|---|---|
| Low-morning-carbohydrate | Experimental | Behavioral: High/low carbohydrate distributionLow morning intake and high evening intake of carbohydrates. This means a distribution of carbohydrate as follows: 10% morning, 40% lunch, 50% dinner. The overall recommendations for macro- and micronutrient intake for GDM patients will be met. |
| High-morning-carbohydrate | Experimental | Behavioral: High/low carbohydrate distributionHigh morning intake and low evening intake of carbohydrates. This means a distribution of carbohydrate as follows: 50% morning, 40% lunch, 10% dinner. The overall recommendations for macro- and micronutrient intake for GDM patients will be met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Gestational diabetes mellitus diagnosed according to current WHO criteria for a 2-hour oral glucose tolerance test (OGTT) > 8.5 mmol/l
- Non-insulin depending
- Adult 18+ years
- Gestational age weeks 30-36 at start of inclusion
Key exclusion criteria (9 listed)
- Diagnosed with celiac disease
- Received bariatric surgery
- Diagnosed eating disorder
- Insulin-dependent diabetes at trial start
- Known with type 2 diabetes before pregnancy
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 |
|---|---|---|
| High/low carbohydrate distributionAlso: High-energy breakfasting compared with high-energy dinnerA total of 2x3 days, were the patient follow a detailed diet plan. For 3 days they follow a diet plan where the majority of the carbohydrates are located on either the first part of the day(HMK) or the last part of the day(LMK). 4 days of washout are placed between the two interventions. They will not receive food but will be guided by a trained dietitian and the use of a meal plan. | Behavioural | High-morning-carbohydrate, Low-morning-carbohydrate |
Primary outcome
mean amplitude of glucose excursions (MAGE)
Time frame: 6 days
An index for glycemic variability assessment MAGE is the average variation in amplitude and is calculated as the mean of absolute value differences between adjacent glucose peaks and valleys, where the differences exceed 1 Standard Deviation (SD) from the mean.
5 secondary outcomes
Coefficient of variation
Time frame: 6 days
MBG
Time frame: 6 days
Glucagon-like-peptide 1 (GLP1)
Time frame: 1 hour *2
Gastric inhibitory polypeptide (GIP)
Time frame: 1 hour*2
C-peptide
Time frame: 11 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Per G Ovesen, Dr.Med study director
Women's diseases and births
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High/low carbohydrate distribution in people with Diabetes, Gestational, run by University of Aarhus at 2 sites in Denmark.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 30 Sep 2019. 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 Denmark. 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?
Results are not available in the source record.
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?
mean amplitude of glucose excursions (MAGE) (time frame: 6 days). 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 30 Sep 2019.