Gestational Diabetes MellitusNCT01719029
Role of Macronutrient Diet Composition and Infant Metabolic Outcomes in Gestational Diabetes
A study testing Low-Carbohydrate/Higher Fat Diet and High Carbohydrate/Low fat diet in people with Gestational Diabetes Mellitus, run by University of Colorado, Denver at 1 site in United States.
Trial summary
A better understanding of the optimal diet for women with gestational diabetes is fundamental to the management of this rapidly growing problem in pregnancy. Careful comparison studies of the current low- carbohydrate, higher-fat diet versus a diet higher in complex carbohydrate but lower in fat is critical in order… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Low-Carbohydrate/Higher Fat Diet and High Carbohydrate/Low fat diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Feb 2015
- 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
Inclusion Criteria:Inclusion Criteria. Potential participants will be ≥ 0-36 years old, which includes the offspring of the pregnant mothers with GDM. Pregnant women will be between the ages of 18-40 years and will have a BMI of 26 - 35 kg/m2 at the time of diagnosis, a singleton pregnancy, and will not be taking medication for their GDM on entrance to the study. Subjects will have been diagnosed with GDM according to the criteria established by the ADA and the ACOG (19;35;53), specifically, they will meet the following criteria:
- A 50-gram Glucola in which the one hour reading is >200 mg/dL and the FBG is >95 mg/dL
- Two abnormal values on a 100-gram 3 hour glucose tolerance test based on the Coustan and Carpenter criteria as adopted by the ADA and Fourth International Workshop on Gestational Diabetes (76;77):
- Fasting > or = to 95 mg/dL but <126 mg/dL
- 1 hr >/= 180 mg/dL
- 2 hr >/= 155 mg/dL
- 3 hr >/=140 mg/dL
Exclusion Criteria:Those women with overt diabetes and those suspected of having preexisting diabetes by any of the following criteria will be excluded, including:
- Fasting glucose >110 mg/dL, due to the high likelihood of rapidly failing diet and requiring medical treatment (35).
- Random glucose > 200 mg/dL
- Glycosylated hemoglobin A1C > 6.5
- Non-English speaking patient
- Fasting TG > 400 mg/dL
Women who smoke will be excluded since this is the leading cause of low birth weight. In addition, women with other risk factors for placental insufficiency, including hypertension requiring beta-blocker treatment, renal disease, thrombophilias, preeclampsia, steroid use, history of pancreatitis or infectious disease such as hepatitis, or intrauterine growth restriction will be excluded.
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Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Role of Macronutrient Diet Composition on Maternal and Infant Metabolic Outcomes in Gestational Diabetes
A better understanding of the optimal diet for women with gestational diabetes is fundamental to the management of this rapidly growing problem in pregnancy. Careful comparison studies of the current low- carbohydrate, higher-fat diet versus a diet higher in complex carbohydrate but lower in fat is critical in order to determine which diet results in a more favorable maternal 24-hour glucose, lipid, and inflammatory profile, all of which directly effect optimal fetal growth and may influence the future health of the offspring.
Read the detailed description
Despite the doubling in the prevalence of gestational diabetes mellitus (GDM) over the last 10 years, dietary management guidelines remain ambiguous due to the paucity of randomized controlled trials. New diagnostic criteria recently developed for the diagnosis of GDM are expected to increase the prevalence to 10-15% of all pregnant women. There is growing recognition that GDM has long-term implications on maternal risk for diabetes and that the intrauterine GDM environment is an independent risk factor for childhood obesity and impaired glucose tolerance. Yet, how diet can be used to modify fetal fuel and attenuate this risk remains unknown in humans. Fundamental to the management of GDM is dietary intervention, yet the historic practice of advising a low-carbohydrate (CHO), higher-fat diet has not been sufficiently tested. Both animal and non-human primate data support a fetal programming influence that maternal high-fat diets may promote insulin resistance, glucose intolerance, and hepatic steatosis in the offspring. Recent human data suggest that high maternal triglycerides (TG) and free fatty acids (FFA), variables sensitive to dietary manipulation, are independent risk factors for fetal macrosomia and adiposity. As a result, consensus groups have abandoned any specific diet recommendations for women with GDM. Despite the pivotal role of diet therapy in the treatment of GDM, no randomized trials have directly compared glycemic and lipoprotein profiles of the conventional higher-fat diet with any other diet. To address this critical need, the aims of this randomized cross-over trial are to study the effects of a high complex carbohydrate/low-fat diet (HC/LF; 60% CHO, 25% fat, 15% protein) compared to the usual care, low-CHO/higher fat diet (LC/HF; 40% CHO, 45% fat, and 15% protein) in GDM women on: 1) 72-hour glycemic profiles using a continuous glucose monitoring system within subjects; 2) postprandial lipemia by measuring serial plasma TG and FFA over a 5-hour, post-breakfast meal period within subjects; and 3) maternal lipoproteins, inflammatory profiles, and in-vitro adipose tissue lipolysis after 6-8 weeks of diet therapy between subjects. We will also measure neonatal adiposity by air displacement plethysmography and newborn markers of lipid peroxidation, inflammation, and dietary fat intake in the babies born to mothers with GDM. This pilot study will directly test which GDM diet is most effective in limiting maternal hyperglycemia and hyperlipidemia in a randomized controlled fashion, potentially optimizing fetal substrate availability and fetal growth. Our goal is to determine which diet intervention might favorably impact a cycle that could otherwise perpetuate future diabetes, obesity, and CVD in both mother and offspring.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Low-Carbohydrate/Higher Fat Diet, High Carbohydrate/Low fat diet
- Keywords
- continuous glucose monitoring, gestational diabetes, diet therapy
- 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/Higher Fat DietOther
High Carbohydrate/Low fat dietOther
| Study group | Role | What they receive |
|---|---|---|
| Conventional Diet | Experimental | Low carbohydrate/higher fat diet: 40% carbohydrate, 45% fat, 15% protein Receives: Other: High Carbohydrate/Low fat diet |
| Complex Carbohydrate Diet | Experimental | High complex carbohydrate/lower fat diet: 60% complex carbohydrate, 25% fat, 15% protein Receives: Other: Low-Carbohydrate/Higher Fat Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose area-under-the-curve
The average glucose area-under-the-curve over 3 days, calculated using 24-hour continuous glucose monitoring
Measured: During 3 days of each diet treatment
Secondary outcomes (1)
Infant Adiposity
Infant adiposity measured using Pea Pod
Measured: 2 weeks after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startAug 2007
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719029
- Sponsor's protocol ID
- 07-0283
- Status last verified
- Jun 2015
- First submitted
- 29 Oct 2012
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hernandez TL, Van Pelt RE, Anderson MA, Reece MS, Reynolds RM, de la Houssaye BA, Heerwagen M, Donahoo WT, Daniels LJ, Chartier-Logan C, Janssen RC, Friedman JE, Barbour LA. Women With Gestational Diabetes Mellitus Randomized to a Higher-Complex Carbohydrate/Low-Fat Diet Manifest Lower Adipose Tissue Insulin Resistance, Inflammation, Glucose, and Free Fatty Acids: A Pilot Study. Diabetes Care. 2016 Jan;39(1):39-42. doi: 10.2337/dc15-0515. Epub 2015 Jul 29.
PubMed 26223240
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Macronutrient Diet Composition on Maternal and Infant Metabolic Outcomes in Gestational Diabetes
- ClinicalTrials.gov ID
- NCT01719029
- Acronym / sponsor ID
- 07-0283
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- continuous glucose monitoring, gestational diabetes, diet therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Kaiser Permanente
- Study start
- Aug 2007
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 1 Nov 2012 (estimated)
- 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.
A better understanding of the optimal diet for women with gestational diabetes is fundamental to the management of this rapidly growing problem in pregnancy. Careful comparison studies of the current low- carbohydrate, higher-fat diet versus a diet higher in complex carbohydrate but lower in fat is critical in order to determine which diet results in a more favorable maternal 24-hour glucose, lipid, and inflammatory profile, all of which directly effect optimal fetal growth and may influence the future health of the offspring.
Detailed description
Despite the doubling in the prevalence of gestational diabetes mellitus (GDM) over the last 10 years, dietary management guidelines remain ambiguous due to the paucity of randomized controlled trials. New diagnostic criteria recently developed for the diagnosis of GDM are expected to increase the prevalence to 10-15% of all pregnant women. There is growing recognition that GDM has long-term implications on maternal risk for diabetes and that the intrauterine GDM environment is an independent risk factor for childhood obesity and impaired glucose tolerance. Yet, how diet can be used to modify fetal fuel and attenuate this risk remains unknown in humans. Fundamental to the management of GDM is dietary intervention, yet the historic practice of advising a low-carbohydrate (CHO), higher-fat diet has not been sufficiently tested. Both animal and non-human primate data support a fetal programming influence that maternal high-fat diets may promote insulin resistance, glucose intolerance, and hepatic steatosis in the offspring. Recent human data suggest that high maternal triglycerides (TG) and free fatty acids (FFA), variables sensitive to dietary manipulation, are independent risk factors for fetal macrosomia and adiposity. As a result, consensus groups have abandoned any specific diet recommendations for women with GDM. Despite the pivotal role of diet therapy in the treatment of GDM, no randomized trials have directly compared glycemic and lipoprotein profiles of the conventional higher-fat diet with any other diet. To address this critical need, the aims of this randomized cross-over trial are to study the effects of a high complex carbohydrate/low-fat diet (HC/LF; 60% CHO, 25% fat, 15% protein) compared to the usual care, low-CHO/higher fat diet (LC/HF; 40% CHO, 45% fat, and 15% protein) in GDM women on: 1) 72-hour glycemic profiles using a continuous glucose monitoring system within subjects; 2) postprandial lipemia by measuring serial plasma TG and FFA over a 5-hour, post-breakfast meal period within subjects; and 3) maternal lipoproteins, inflammatory profiles, and in-vitro adipose tissue lipolysis after 6-8 weeks of diet therapy between subjects. We will also measure neonatal adiposity by air displacement plethysmography and newborn markers of lipid peroxidation, inflammation, and dietary fat intake in the babies born to mothers with GDM. This pilot study will directly test which GDM diet is most effective in limiting maternal hyperglycemia and hyperlipidemia in a randomized controlled fashion, potentially optimizing fetal substrate availability and fetal growth. Our goal is to determine which diet intervention might favorably impact a cycle that could otherwise perpetuate future diabetes, obesity, and CVD in both mother and offspring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Diet | Experimental | Other: High Carbohydrate/Low fat dietLow carbohydrate/higher fat diet: 40% carbohydrate, 45% fat, 15% protein |
| Complex Carbohydrate Diet | Experimental | Other: Low-Carbohydrate/Higher Fat DietHigh complex carbohydrate/lower fat diet: 60% complex carbohydrate, 25% fat, 15% protein |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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/Higher Fat Diet | Other | Complex Carbohydrate Diet |
| High Carbohydrate/Low fat diet | Other | Conventional Diet |
Primary outcome
Glucose area-under-the-curve
Time frame: During 3 days of each diet treatment
The average glucose area-under-the-curve over 3 days, calculated using 24-hour continuous glucose monitoring
1 secondary outcome
Infant Adiposity
Time frame: 2 weeks after birth
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 10 Jun 2015.
- Derived from this study: PubMed 26223240Hernandez TL, Van Pelt RE, Anderson MA, Reece MS, Reynolds RM, de la Houssaye BA, Heerwagen M, Donahoo WT, Daniels LJ, Chartier-Logan C, Janssen RC, Friedman JE, Barbour LA. Women With Gestational Diabetes Mellitus Randomized to a Higher-Complex Carbohydrate/Low-Fat Diet Manifest Lower Adipose Tissue Insulin Resistance, Inflammation, Glucose, and Free Fatty Acids: A Pilot Study. Diabetes Care. 2016 Jan;39(1):39-42. doi: 10.2337/dc15-0515. Epub 2015 Jul 29.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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/Higher Fat Diet and High Carbohydrate/Low fat diet in people with Gestational Diabetes Mellitus, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Jun 2015. 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 United States. 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?
Glucose area-under-the-curve (time frame: During 3 days of each diet treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01719029, which also lists 1 linked publication.
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 10 Jun 2015.