Gestational DiabetesNCT04051359
Carbohydrate Restriction in Pregnant Women With Gestation Diabetes Mellitus
A study testing Low carbohydrate (130 g) diet in people with Gestational Diabetes, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The purpose of this controlled, randomized intervention is to investigate whether a carbohydrate-restricted diet, having a positive effect on blood sugar and weigh maintaining in diabetes, is effective and safe for pregnant woman with GDM and safe for their offspring, when compared to the standard carbohydrate content… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Low carbohydrate (130 g) diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Aug 2019to 15 Aug 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18-45 years
- GDM diagnosed between 12 and 34 weeks gestation according to Carpenter and Coustan criteria (13)
- BMI 20-35 kg/m2
- Singleton pregnancy
- Willing to perform self-monitoring of blood glucose at least 4 times a day
- Self-monitoring of blood glucose
- 12 to 34 weeks of gestation at the time of randomization
- Signed informed consent
Who cannot join
- Pre-existing diabetes in pregnancy, including first trimester fasting glucose ≥105 mg/dL
- Use of other oral hypoglycemic agents during this pregnancy
- Multiple pregnancy
- Known hepatic insufficiency (bilirubin >50 µmol/L and/or protrombin time <50 %)
- Insufficient understanding
- Participant in another investigational drug study at inclusion visits
- Fetal malformation diagnosed by previous fetal ultrasound
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Department of Endocrinology, Metabolism and Hypertension, Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239
Marianna Yaron, MD, +972544851224, mariannayaron@gmail.com
About this study
Official title: Effectiveness and Safety of Two Different Diets in Terms of Carbohydrate Restriction in Pregnant Women With Gestation Diabetes Mellitus
The purpose of this controlled, randomized intervention is to investigate whether a carbohydrate-restricted diet, having a positive effect on blood sugar and weigh maintaining in diabetes, is effective and safe for pregnant woman with GDM and safe for their offspring, when compared to the standard carbohydrate content diet.
Read the detailed description
Increasing prevalence of obesity and tendency to become pregnant later in life can explain rising prevalence of gestation diabetes (GDM) (1). Diabetes in pregnancy is a major public health issue: it has been shown that the mother's glycemic levels correlates perfectly with child's birth weight, death in utero, perinatal mortality and hypoglycemia (2). Therapeutic management is relatively simple and based on correction of hyperglycemia by carbohydrate restriction and energy-controlled diet adapted to pre-pregnancy BMI (3).
Although restriction of dietary carbohydrate has been the cornstone for treatment of GDM (4,5) with ACOG and The Endocrine Society recommendation for carbohydrate intake to 33-40% of total daily calories, the paucity of RCT evidence supporting safety of carbohydrate restriction still exist and actual dietary composition that optimizes perinatal outcomes is unknown (3).
Carbohydrate restriction in GDM comes with the potential increases in dietary fat intake and consequently a strong association between maternal lipids (i.e., triglycerides and free fatty acids) and excess fetal growth (6). Moreover, restrictive caloric and carbohydrate diet increases ketogenesis and ketone bodies (acetoacetate and beta-hydroxybutyrate (BHB) cross well the placental barrier.
Gestational ketogenic diet in mouse deleteriously affects the offspring growth and brain development (7), an early postnatal exposure to a ketogenic diet results in significant alterations to neonatal brain structure and can be accompanied by functional and behavioral changes in later postnatal life (8).
In the second half of pregnancy, under the influence of increasing placental hormones and cytokine concentration, lipolysis become dominant and use of free fatty acids as the energy material for the mother's body in place of glucose that is consumed mostly by the fetus.
These mechanisms are responsible for increased ketogenesis during pregnancy and are three times higher at night among pregnant women than among nonpregnant women (16). Human studies focused mostly exclusively on ketonuria; and a negative correlation between ketonuria and intellectual quotient in children born to diabetic mothers have been reported (9). Rizzo et al. did not confirm this correlation, although the authors did reveal a negative correlation between maternal β-hydroxybutyrate concentration in blood and the child's mental development (10).
On the other hand, evaluating ketone production in early pregnancy with type 1 diabetes by measuring blood BHB, the Jovanovic et al. found that despite the significantly elevated blood BHB level (2.5-fold higher than nondiabetic pregnant at 6th week gestation, and 1.6-fold at 12th week gestation), there was trend to lower BHB level in diabetic and nondiabetic mothers with malformed infants and pregnancy loss. The level of BHB was lower also in diabetic mothers of macrosomic infants (11).
Recently, inexpensive quantitative test of BHB became available using small capillary blood sample. Therefore, we would like to evaluate the levels of BHB in GDM patients treated by two different carbohydrate restricted diets in order to add an evidence on safety and proper caloric and carbohydrate restriction recommendation during pregnancy in order to optimize maternal and perinatal outcomes.
- Conditions
- Gestational Diabetes
- Being tested
- Low carbohydrate (130 g) diet
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low carbohydrate (130 g) dietOther
Isocaloric moderately reduced carbohydrate diet (RCD, reduced carbohydrate diet) (~130 grams of carbohydrates)
| Study group | Role | What they receive |
|---|---|---|
| Standard carbohydrate (200 g) group | Active comparator | Assignment to treatment groups will be performed on the enrollment to the study by evaluating the dietary carbohydrate intake personal patient preferences from 3 days prospective 24 hours' food dairy. After, the randomization will be performed and GDM patients will be assigned to the standard carbohydrate (200 g) group. Receives: Other: Low carbohydrate (130 g) diet |
| Low carbohydrate (130 g) group | Experimental | Assignment to treatment groups will be performed on the enrollment to the study by evaluating the dietary carbohydrate intake personal patient preferences from 3 days prospective 24 hours' food dairy. After, the randomization will be performed and GDM patients will be assigned to the low carbohydrate (130 g) group. Receives: Other: Low carbohydrate (130 g) diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of treatment failure defined as patients needing additional hypoglycemic therapy by long-insulin acting analogue detemir evaluated by capillary glucose levels
- The treatment failure would be defined if the fasting SMBG would be ≥95 mg/dl and/or if 1-hour post-prandial (PP) BG would be ≥140 mg/dl or 2 hour PP BG would be ≥120 mg/dl in >20% of the measurements
Measured: From one week after inclusion : 13 to 36 weeks of gestation to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start15 Aug 2019 (estimated)
- Primary completion15 Feb 2021 (estimated)
- Study completion15 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Parallel groups
- Model description
- Randomized trial
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051359
- Sponsor's protocol ID
- 0244-18-TLV
- Status last verified
- Aug 2019
- First submitted
- 8 Aug 2019
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All women will be instructed to keep a diet of 25 kcal/kg/day for overweight and obese (pre-pregnancy BMI \>25) and 35 kcal/kg for women with normal weight (pre-pregnancy BMI 18.5-24.9). The intervention (low carbohydrate intake = RCD) group will be instructed to keep a diet divided into 3 full meals and four snacks of 130 g/d (or at least 20% of total daily caloric intake) of carbohydrate intake and high protein and high fat intake from plant-source foods (35-55% fat, and 20-25% protein). Protein content will be the same amount in both groups. The standard carbohydrate diet (control group) group will be instructed to keep a diet divided into 3 full meals and four snacks of 200 g/d (or at least 40% of total daily caloric intake) of carbohydrate intake and high protein and high fat intake from plant-source foods (35-45% fat, and 20-25% protein).
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Two Different Diets in Terms of Carbohydrate Restriction in Pregnant Women With Gestation Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04051359
- Acronym / sponsor ID
- 0244-18-TLV
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 15 Aug 2019 (estimated)
- Primary completion
- 15 Feb 2021 (estimated)
- Study completion
- 15 Aug 2021 (estimated)
- First posted
- 9 Aug 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.
The purpose of this controlled, randomized intervention is to investigate whether a carbohydrate-restricted diet, having a positive effect on blood sugar and weigh maintaining in diabetes, is effective and safe for pregnant woman with GDM and safe for their offspring, when compared to the standard carbohydrate content diet.
Detailed description
Increasing prevalence of obesity and tendency to become pregnant later in life can explain rising prevalence of gestation diabetes (GDM) (1). Diabetes in pregnancy is a major public health issue: it has been shown that the mother's glycemic levels correlates perfectly with child's birth weight, death in utero, perinatal mortality and hypoglycemia (2). Therapeutic management is relatively simple and based on correction of hyperglycemia by carbohydrate restriction and energy-controlled diet adapted to pre-pregnancy BMI (3).
Although restriction of dietary carbohydrate has been the cornstone for treatment of GDM (4,5) with ACOG and The Endocrine Society recommendation for carbohydrate intake to 33-40% of total daily calories, the paucity of RCT evidence supporting safety of carbohydrate restriction still exist and actual dietary composition that optimizes perinatal outcomes is unknown (3).
Carbohydrate restriction in GDM comes with the potential increases in dietary fat intake and consequently a strong association between maternal lipids (i.e., triglycerides and free fatty acids) and excess fetal growth (6). Moreover, restrictive caloric and carbohydrate diet increases ketogenesis and ketone bodies (acetoacetate and beta-hydroxybutyrate (BHB) cross well the placental barrier.
Gestational ketogenic diet in mouse deleteriously affects the offspring growth and brain development (7), an early postnatal exposure to a ketogenic diet results in significant alterations to neonatal brain structure and can be accompanied by functional and behavioral changes in later postnatal life (8).
In the second half of pregnancy, under the influence of increasing placental hormones and cytokine concentration, lipolysis become dominant and use of free fatty acids as the energy material for the mother's body in place of glucose that is consumed mostly by the fetus.
These mechanisms are responsible for increased ketogenesis during pregnancy and are three times higher at night among pregnant women than among nonpregnant women (16). Human studies focused mostly exclusively on ketonuria; and a negative correlation between ketonuria and intellectual quotient in children born to diabetic mothers have been reported (9). Rizzo et al. did not confirm this correlation, although the authors did reveal a negative correlation between maternal β-hydroxybutyrate concentration in blood and the child's mental development (10).
On the other hand, evaluating ketone production in early pregnancy with type 1 diabetes by measuring blood BHB, the Jovanovic et al. found that despite the significantly elevated blood BHB level (2.5-fold higher than nondiabetic pregnant at 6th week gestation, and 1.6-fold at 12th week gestation), there was trend to lower BHB level in diabetic and nondiabetic mothers with malformed infants and pregnancy loss. The level of BHB was lower also in diabetic mothers of macrosomic infants (11).
Recently, inexpensive quantitative test of BHB became available using small capillary blood sample. Therefore, we would like to evaluate the levels of BHB in GDM patients treated by two different carbohydrate restricted diets in order to add an evidence on safety and proper caloric and carbohydrate restriction recommendation during pregnancy in order to optimize maternal and perinatal outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized trial
| Arm | Type | Receives |
|---|---|---|
| Standard carbohydrate (200 g) group | Active comparator | Other: Low carbohydrate (130 g) dietAssignment to treatment groups will be performed on the enrollment to the study by evaluating the dietary carbohydrate intake personal patient preferences from 3 days prospective 24 hours' food dairy. After, the randomization will be performed and GDM patients will be assigned to the standard carbohydrate (200 g) group. |
| Low carbohydrate (130 g) group | Experimental | Other: Low carbohydrate (130 g) dietAssignment to treatment groups will be performed on the enrollment to the study by evaluating the dietary carbohydrate intake personal patient preferences from 3 days prospective 24 hours' food dairy. After, the randomization will be performed and GDM patients will be assigned to the low carbohydrate (130 g) group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Ages 18-45 years
- GDM diagnosed between 12 and 34 weeks gestation according to Carpenter and Coustan criteria (13)
- BMI 20-35 kg/m2
- Singleton pregnancy
- Willing to perform self-monitoring of blood glucose at least 4 times a day
Key exclusion criteria (7 listed)
- Pre-existing diabetes in pregnancy, including first trimester fasting glucose ≥105 mg/dL
- Use of other oral hypoglycemic agents during this pregnancy
- Multiple pregnancy
- Known hepatic insufficiency (bilirubin >50 µmol/L and/or protrombin time <50 %)
- Insufficient understanding
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 |
|---|---|---|
| Low carbohydrate (130 g) dietIsocaloric moderately reduced carbohydrate diet (RCD, reduced carbohydrate diet) (~130 grams of carbohydrates) | Other | Low carbohydrate (130 g) group, Standard carbohydrate (200 g) group |
Primary outcome
The rate of treatment failure defined as patients needing additional hypoglycemic therapy by long-insulin acting analogue detemir evaluated by capillary glucose levels
Time frame: From one week after inclusion : 13 to 36 weeks of gestation to delivery
o The treatment failure would be defined if the fasting SMBG would be ≥95 mg/dl and/or if 1-hour post-prandial (PP) BG would be ≥140 mg/dl or 2 hour PP BG would be ≥120 mg/dl in >20% of the measurements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Individual participant dataSharing planned: Undecided. All women will be instructed to keep a diet of 25 kcal/kg/day for overweight and obese (pre-pregnancy BMI >25) and 35 kcal/kg for women with normal weight (pre-pregnancy BMI 18.5-24.9). The intervention (low carbohydrate intake = RCD) group will be instructed to keep a diet divided into 3 full meals and four snacks of 130 g/d (or at least 20% of total daily caloric intake) of carbohydrate intake and high protein and high fat intake from plant-source foods (35-55% fat, and 20-25% protein). Protein content will be the same amount in both groups. The standard carbohydrate diet (control group) group will be instructed to keep a diet divided into 3 full meals and four snacks of 200 g/d (or at least 40% of total daily caloric intake) of carbohydrate intake and high protein and high fat intake from plant-source foods (35-45% fat, and 20-25% protein).
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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.
Department of Endocrinology, Metabolism and Hypertension, Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low carbohydrate (130 g) diet in people with Gestational Diabetes, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 8 inclusion and 7 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 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of treatment failure defined as patients needing additional hypoglycemic therapy by long-insulin acting analogue detemir evaluated by capillary glucose levels (time frame: From one week after inclusion : 13 to 36 weeks of gestation to delivery). 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 9 Aug 2019.