Gestational DiabetesPROMISNCT04315545
Pregnancy Outcomes and Maternal Insulin Sensitivity
An observational study of Gestational Diabetes and Other "Heavy-For-Dates" Infants, run by University Medical Center Groningen at 2 sites in Netherlands.
Trial summary
The PROMIS study will focus on maternal insulin sensitivity thourghout pregnancy and postpartum in a moderate to high risk population (BMI ≥25 kg/m2) in developing adverse pregnancy outcomes. Next to the OGTT, the meal tolerance test (MTT) will be used as a tool for metabolic testing. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes, Other "Heavy-For-Dates" Infants, Small for Gestational Age Infant
- What is being tested?
- meal tolerance test
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 2 sitesNetherlands
- Study dates
- 6 Feb 2020to 8 Jul 2024
- How long will I take part?
- 10 Months
- Phase
- Observational
- 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
- No healthy volunteers
- Adult
Study population: The study population will be pregnant women with a BMI ≥25 kg/m2 with a moderate to high 'at risk' of developing gestational diabetes throughout pregnancy
Who may be able to join
- Healthy singleton pregnant women (10-12 weeks of gestation)
- BMI ≥25 kg/m2
- FPG ≤7.0 mmol/l
- Dutch or English speaking
- Written informed consent
Who cannot join
- Serious health complications (Hypertension, Hyperlipidemia, Asthma, Haemochromatosis) or medication use that influence the glucose metabolism or fetal growth (e.g. corticosteroids).
- Multiple pregnancy
- pre-existing Diabetes type 1 and 2 defined as FPG ≥7.0 mmol/l or use of diabetes medication
- Participation in any other studies involving the investigation of medication or nutritional products or severe illness or antibiotic use in the two weeks prior to entry into the study
- HIV/Hepatitis
- Expectation of non-compliance to the study protocol, among others, a fear of needles
- Known allergies or intolerances for one or more nutritional ingredients in the MTT
- Psychological dysfunctions
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
University Medical Centre Groningen
Groningen, 9713 GZ
Medical Center Leeuwarden
Leeuwarden, 8984 AD
About this study
The PROMIS study will focus on maternal insulin sensitivity thourghout pregnancy and postpartum in a moderate to high risk population (BMI ≥25 kg/m2) in developing adverse pregnancy outcomes. Next to the OGTT, the meal tolerance test (MTT) will be used as a tool for metabolic testing.
The investigators hypothesize that (early) pregnancy assessment of maternal glucose-insulin metabolism with a MTT in a moderate to high risk group identify more mothers at risk for adverse pregnancy outcomes compared with standard OGTT testing at 24-28 weeks.
Read the detailed description
The worldwide prevalence of overweight and obesity is rapidly increasing, also affecting women of reproductive age. The prevalence of overweight women between 30-40 years in the Netherlands in 2017 was 39%. Women with a BMI ≥25 kg/m2 have excess adipose tissue which reduces insulin sensitivity and explains the correlated adverse outcomes for both mother and child.
Insulin sensitivity changes over the course of pregnancy due to the effect of placental hormones and is therefore normally decreased by the end of the second trimester to ensure a continuous supply of nutrients towards the growing fetus. Insulin resistance leads to beta-cell proliferation and larger volume of individual beta-cells, returning to non-pregnant levels after parturition. When beta-cell proliferation is not or inadequately increased, this may lead to hyperglycemia. It is shown that small increases in maternal glucose levels have a linear relationship with adverse outcomes. Maternal adverse outcomes are pre-eclampsia, caesarian section and gestational diabetes mellitus (GDM) on the short term and increased risk of weight retention and non-communicable diseases like cardiovascular diseases and diabetes mellitus type 2 (DM2) on the longer term. Adverse outcomes in infants are macrosomia, large for gestational age (LGA), small for gestational age (SGA) on the short term and a higher risk on childhood obesity and non-communicable diseases on the longer term. Adequate maternal insulin sensitivity throughout pregnancy is therefore critical.
Small maternal glucose increases could already be detected in an early stage of pregnancy. In the Netherlands hyperglycemia is standardly examined at the end of the second trimester in an at risk population by an oral glucose tolerance test (OGTT). This test is less suitable to detect mild hyperglycemia in early stages of pregnancy, with merely blood glucose levels as a result, and shows a lot of within subject variability. However markers of insulin sensitivity and related metabolic adaptations, for instance in lipid metabolism, may be a more straightforward measure that could potentially be detected earlier and allow for early intervention. An integration of postprandial responses of glucose/insulin following a meal challenge combined with lipid markers could provide clearer insights in maternal metabolic function. A test that could be used to examine this in more detail is a liquid meal tolerance test (MTT) which contains a balanced macro- and micronutrient composition. Assessing glucose homeostasis is not possible by only measuring glucose concentrations as there are numerous perturbations where glucose production and its utilization increases or decreases to the same extent without any changes in concentrations. For the understanding of the physiology and pathophysiology of glucose uptake and metabolism during pregnancy, glucose tracers should be followed.
The PROMIS study will specifically focus on the associations between insulin sensitivity in the mother in early pregnancy and fetal and neonatal outcomes with emphasis on growth and body composition. The investigators therefore hypothesize that when overweight pregnant women are challenged in early pregnancy with a MTT, the group of women with disturbed insulin sensitivity could be identified much earlier, and can therefore have a predictive role in adverse outcomes.
- Conditions
- Gestational Diabetes, Other "Heavy-For-Dates" Infants, Small for Gestational Age Infant, Diabetes Mellitus, Type 2
- Being tested
- meal tolerance test
- Keywords
- Insulin sensitivity, Insulin insensitivity, Pregnancy, Metabolism, Neonatal outcomes, glucose metabolism, Oral glucose tolerance test, Meal tolerance test, neonatal health, maternal health, maternal insulin sensitivity, gestational weight gain, diagnostic tool, early screening, prevention, overweight, obesitiy, metabolic health, neonatal adiposity, maternal adiposity
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus, Type 2, Insulin Resistance, Gestational Weight Gain, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meal tolerance testDiagnostic test
In addition to the standard oral glucose tolerance (which is normally performed between 24-28 weeks of pregnancy), is used to test the metabolic resilience capacity of glucose, we will provide our participants with a different diagnostic tool named 'meal tolerance test' in an earlier stage of pregnancy (12-16 weeks), mid pregnancy (24-28 weeks) and 3 months postpartum.
| Study group | Role | What they receive |
|---|---|---|
| Healthy women pregnant of singleton with a BMI ≥25 kg/m2 | Healthy women pregnant of singleton with a BMI ≥25 kg/m2 will be followed from 12 weeks of gestation till 6 months postpartum. Neonates will be followed from birth up to 6 months of age. Receives: Diagnostic Test: meal tolerance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting glucose
Bloood will be collected fasted and after intake of the MTT and OGTT
Measured: T=0 min, before intake of test drink
postprandial glucose
Bloood will be collected fasted and after intake of the MTT and OGTT
Measured: T=10 min postprandial
postprandial glucose
Bloood will be collected fasted and after intake of the MTT and OGTT
Measured: T=20 min postprandial
postprandial glucose
Bloood will be collected fasted and after intake of the MTT and OGTT
Measured: T=30 min postprandial
postprandial glucose
Bloood will be collected fasted and after intake of the MTT and OGTT
Measured: T=45 min postprandial
postprandial glucose
Bloood will be collected fasted and after intake of the MTT and OGTT
Measured: T=60 min postprandial
postprandial glucose
Bloood will be collected fasted and after intake of the MTT and OGTT
Measured: T=90 min postprandial
postprandial glucose
Bloood will be collected fasted and after intake of the MTT and OGTT
Measured: T=120 min postprandial
fasting and postprandial glucose
Bloood will be collected fasted and after intake of the MTT and OGTT
Measured: AUC and postprandial curve
fasting insulin
Blood will be collected fasted and after intake of the MTT and OGTT
Measured: T=0 min, before intake of test drink
postprandial insulin
Blood will be collected fasted and after intake of the MTT and OGTT
Measured: T=10 min postprandial
postprandial insulin
Blood will be collected fasted and after intake of the MTT and OGTT
Measured: T=20 min postprandial
postprandial insulin
Blood will be collected fasted and after intake of the MTT and OGTT
Measured: T=30 min postprandial
postprandial insulin
Blood will be collected fasted and after intake of the MTT and OGTT
Measured: T=45 min postprandial
postprandial insulin
Blood will be collected fasted and after intake of the MTT and OGTT
Measured: T=60 min postprandial
postprandial insulin
Blood will be collected fasted and after intake of the MTT and OGTT
Measured: T=90 min postprandial
postprandial insulin
Blood will be collected fasted and after intake of the MTT and OGTT
Measured: T=120 min postprandial
fasting and postprandial insulin
Blood will be collected fasted and after intake of the MTT and OGTT
Measured: AUC and postprandial curve
Secondary outcomes (14)
Triglycerides
Blood will be collected fasted
Measured: T=0 min, before intake of test drink
Total cholesterol
Blood will be collected fasted
Measured: T=0 min, before intake of test drink
HDL-cholesterol
Blood will be collected fasted
Measured: T=0 min, before intake of test drink
Free fatty acids
Blood will be collected fasted
Measured: T=0 min, before intake of test drink
Hba1c
Blood will be collected fasted
Measured: T=0 min, before intake of test drink
Fasting stable glucose isotopes
Blood will be collected fasted and after intake of the MTT and OGTT
Measured: T=0, before intake of test drink
postprandial stable glucose isotopes
Blood will be collected fasted and after intake of the MTT and OGTT
Measured: T=10 min postprandial
postprandial stable glucose isotopes
Blood will be collected fasted and after intake of the MTT and OGTT
Measured: T=20 min postprandial
postprandial stable glucose isotopes
Blood will be collected fasted and after intake of the MTT and OGTT
Measured: T=30 min postprandial
postprandial stable glucose isotopes
Blood will be collected fasted and after intake of the MTT and OGTT
Measured: T=45 min postprandial
postprandial stable glucose isotopes
Blood will be collected fasted and after intake of the MTT and OGTT
Measured: T=60 min postprandial
postprandial stable glucose isotopes
Blood will be collected fasted and after intake of the MTT and OGTT
Measured: T=90 min postprandial
postprandial stable glucose isotopes
Blood will be collected fasted and after intake of the MTT and OGTT
Measured: T=120 min postprandial
fasting and postprandial stable glucose isotopes
Blood will be collected fasted and after intake of the MTT and OGTT
Measured: AUC and postprandial curve
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start6 Feb 2020
- Primary completion8 Jul 2024
- Study completion8 Jul 2024
Why it stopped: slow recruitment, reached sufficient recruitment numbers for exploratory analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, eline van der beek, University Medical Center Groningen
- Investigators
- Eline M van der Beek, Prof. Dr., Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315545
- Sponsor's protocol ID
- 68845
- Acronym
- PROMIS
- Status last verified
- Mar 2025
- First submitted
- 20 Feb 2020
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol will be submitted for publication in a peer reviewed journal
Publications
Koning SH, Hoogenberg K, Lutgers HL, van den Berg PP, Wolffenbuttel BH. Gestational Diabetes Mellitus:current knowledge and unmet needs. J Diabetes. 2016 Nov;8(6):770-781. doi: 10.1111/1753-0407.12422. Epub 2016 Jul 28.
PubMed 27121958Venkataraman H, Ram U, Craik S, Arungunasekaran A, Seshadri S, Saravanan P. Increased fetal adiposity prior to diagnosis of gestational diabetes in South Asians: more evidence for the 'thin-fat' baby. Diabetologia. 2017 Mar;60(3):399-405. doi: 10.1007/s00125-016-4166-2. Epub 2016 Dec 2.
PubMed 27913848World Health Organization. World health statistics 2016: Monitoring health for the SDGs sustainable development goals. World Health Organization; 2016.
Ko GT, Chan JC, Woo J, Lau E, Yeung VT, Chow CC, Cockram CS. The reproducibility and usefulness of the oral glucose tolerance test in screening for diabetes and other cardiovascular risk factors. Ann Clin Biochem. 1998 Jan;35 ( Pt 1):62-7. doi: 10.1177/000456329803500107.
PubMed 9463740Maegawa Y, Sugiyama T, Kusaka H, Mitao M, Toyoda N. Screening tests for gestational diabetes in Japan in the 1st and 2nd trimester of pregnancy. Diabetes Res Clin Pract. 2003 Oct;62(1):47-53. doi: 10.1016/s0168-8227(03)00146-3.
PubMed 14581157Seshiah V, Cynthia A, Balaji V, Balaji MS, Ashalata S, Sheela R, Thamizharasi M, Arthi T. Detection and care of women with gestational diabetes mellitus from early weeks of pregnancy results in birth weight of newborn babies appropriate for gestational age. Diabetes Res Clin Pract. 2008 May;80(2):199-202. doi: 10.1016/j.diabres.2007.12.008. Epub 2008 Feb 4.
PubMed 18249458HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
PubMed 18463375NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in body-mass index, underweight, overweight, and obesity from 1975 to 2016: a pooled analysis of 2416 population-based measurement studies in 128.9 million children, adolescents, and adults. Lancet. 2017 Dec 16;390(10113):2627-2642. doi: 10.1016/S0140-6736(17)32129-3. Epub 2017 Oct 10.
PubMed 29029897Chen C, Xu X, Yan Y. Estimated global overweight and obesity burden in pregnant women based on panel data model. PLoS One. 2018 Aug 9;13(8):e0202183. doi: 10.1371/journal.pone.0202183. eCollection 2018.
PubMed 30092099Catalano PM, Ehrenberg HM. The short- and long-term implications of maternal obesity on the mother and her offspring. BJOG. 2006 Oct;113(10):1126-33. doi: 10.1111/j.1471-0528.2006.00989.x. Epub 2006 Jul 7.
PubMed 16827826Zhu Y, Zhang C. Prevalence of Gestational Diabetes and Risk of Progression to Type 2 Diabetes: a Global Perspective. Curr Diab Rep. 2016 Jan;16(1):7. doi: 10.1007/s11892-015-0699-x.
PubMed 26742932Koning SH, van Zanden JJ, Hoogenberg K, Lutgers HL, Klomp AW, Korteweg FJ, van Loon AJ, Wolffenbuttel BHR, van den Berg PP. New diagnostic criteria for gestational diabetes mellitus and their impact on the number of diagnoses and pregnancy outcomes. Diabetologia. 2018 Apr;61(4):800-809. doi: 10.1007/s00125-017-4506-x. Epub 2017 Nov 22.
PubMed 29167927Koning SH, Hoogenberg K, Scheuneman KA, Baas MG, Korteweg FJ, Sollie KM, Schering BJ, van Loon AJ, Wolffenbuttel BH, van den Berg PP, Lutgers HL. Neonatal and obstetric outcomes in diet- and insulin-treated women with gestational diabetes mellitus: a retrospective study. BMC Endocr Disord. 2016 Sep 29;16(1):52. doi: 10.1186/s12902-016-0136-4.
PubMed 27680327Kim C, Newton KM, Knopp RH. Gestational diabetes and the incidence of type 2 diabetes: a systematic review. Diabetes Care. 2002 Oct;25(10):1862-8. doi: 10.2337/diacare.25.10.1862.
PubMed 12351492Feig DS, Zinman B, Wang X, Hux JE. Risk of development of diabetes mellitus after diagnosis of gestational diabetes. CMAJ. 2008 Jul 29;179(3):229-34. doi: 10.1503/cmaj.080012.
PubMed 18663202
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Outcomes and Maternal Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT04315545
- Acronym / sponsor ID
- PROMIS / 68845
- Conditions
- Gestational Diabetes, Other "Heavy-For-Dates" Infants, Small for Gestational Age Infant, Diabetes Mellitus, Type 2
- Keywords
- Insulin sensitivity, Insulin insensitivity, Pregnancy, Metabolism, Neonatal outcomes, glucose metabolism, Oral glucose tolerance test, Meal tolerance test
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: slow recruitment, reached sufficient recruitment numbers for exploratory analysis
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 19 Mar 2020 (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 PROMIS study will focus on maternal insulin sensitivity thourghout pregnancy and postpartum in a moderate to high risk population (BMI ≥25 kg/m2) in developing adverse pregnancy outcomes. Next to the OGTT, the meal tolerance test (MTT) will be used as a tool for metabolic testing.
The investigators hypothesize that (early) pregnancy assessment of maternal glucose-insulin metabolism with a MTT in a moderate to high risk group identify more mothers at risk for adverse pregnancy outcomes compared with standard OGTT testing at 24-28 weeks.
Detailed description
The worldwide prevalence of overweight and obesity is rapidly increasing, also affecting women of reproductive age. The prevalence of overweight women between 30-40 years in the Netherlands in 2017 was 39%. Women with a BMI ≥25 kg/m2 have excess adipose tissue which reduces insulin sensitivity and explains the correlated adverse outcomes for both mother and child.
Insulin sensitivity changes over the course of pregnancy due to the effect of placental hormones and is therefore normally decreased by the end of the second trimester to ensure a continuous supply of nutrients towards the growing fetus. Insulin resistance leads to beta-cell proliferation and larger volume of individual beta-cells, returning to non-pregnant levels after parturition. When beta-cell proliferation is not or inadequately increased, this may lead to hyperglycemia. It is shown that small increases in maternal glucose levels have a linear relationship with adverse outcomes. Maternal adverse outcomes are pre-eclampsia, caesarian section and gestational diabetes mellitus (GDM) on the short term and increased risk of weight retention and non-communicable diseases like cardiovascular diseases and diabetes mellitus type 2 (DM2) on the longer term. Adverse outcomes in infants are macrosomia, large for gestational age (LGA), small for gestational age (SGA) on the short term and a higher risk on childhood obesity and non-communicable diseases on the longer term. Adequate maternal insulin sensitivity throughout pregnancy is therefore critical.
Small maternal glucose increases could already be detected in an early stage of pregnancy. In the Netherlands hyperglycemia is standardly examined at the end of the second trimester in an at risk population by an oral glucose tolerance test (OGTT). This test is less suitable to detect mild hyperglycemia in early stages of pregnancy, with merely blood glucose levels as a result, and shows a lot of within subject variability. However markers of insulin sensitivity and related metabolic adaptations, for instance in lipid metabolism, may be a more straightforward measure that could potentially be detected earlier and allow for early intervention. An integration of postprandial responses of glucose/insulin following a meal challenge combined with lipid markers could provide clearer insights in maternal metabolic function. A test that could be used to examine this in more detail is a liquid meal tolerance test (MTT) which contains a balanced macro- and micronutrient composition. Assessing glucose homeostasis is not possible by only measuring glucose concentrations as there are numerous perturbations where glucose production and its utilization increases or decreases to the same extent without any changes in concentrations. For the understanding of the physiology and pathophysiology of glucose uptake and metabolism during pregnancy, glucose tracers should be followed.
The PROMIS study will specifically focus on the associations between insulin sensitivity in the mother in early pregnancy and fetal and neonatal outcomes with emphasis on growth and body composition. The investigators therefore hypothesize that when overweight pregnant women are challenged in early pregnancy with a MTT, the group of women with disturbed insulin sensitivity could be identified much earlier, and can therefore have a predictive role in adverse outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy women pregnant of singleton with a BMI ≥25 kg/m2 | – | Diagnostic Test: meal tolerance testHealthy women pregnant of singleton with a BMI ≥25 kg/m2 will be followed from 12 weeks of gestation till 6 months postpartum. Neonates will be followed from birth up to 6 months of age. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will be pregnant women with a BMI ≥25 kg/m2 with a moderate to high 'at risk' of developing gestational diabetes throughout pregnancy
Key inclusion criteria (5 listed)
- Healthy singleton pregnant women (10-12 weeks of gestation)
- BMI ≥25 kg/m2
- FPG ≤7.0 mmol/l
- Dutch or English speaking
- Written informed consent
Key exclusion criteria (8 listed)
- Serious health complications (Hypertension, Hyperlipidemia, Asthma, Haemochromatosis) or medication use that influence the glucose metabolism or fetal growth (e.g. corticosteroids).
- Multiple pregnancy
- pre-existing Diabetes type 1 and 2 defined as FPG ≥7.0 mmol/l or use of diabetes medication
- Participation in any other studies involving the investigation of medication or nutritional products or severe illness or antibiotic use in the two weeks prior to entry into the study
- HIV/Hepatitis
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 |
|---|---|---|
| meal tolerance testIn addition to the standard oral glucose tolerance (which is normally performed between 24-28 weeks of pregnancy), is used to test the metabolic resilience capacity of glucose, we will provide our participants with a different diagnostic tool named 'meal tolerance test' in an earlier stage of pregnancy (12-16 weeks), mid pregnancy (24-28 weeks) and 3 months postpartum. | Diagnostic test | Healthy women pregnant of singleton with a BMI ≥25 kg/m2 |
Primary outcome
fasting glucose
Time frame: T=0 min, before intake of test drink
Bloood will be collected fasted and after intake of the MTT and OGTT
postprandial glucose
Time frame: T=10 min postprandial
Bloood will be collected fasted and after intake of the MTT and OGTT
postprandial glucose
Time frame: T=20 min postprandial
Bloood will be collected fasted and after intake of the MTT and OGTT
postprandial glucose
Time frame: T=30 min postprandial
Bloood will be collected fasted and after intake of the MTT and OGTT
postprandial glucose
Time frame: T=45 min postprandial
Bloood will be collected fasted and after intake of the MTT and OGTT
postprandial glucose
Time frame: T=60 min postprandial
Bloood will be collected fasted and after intake of the MTT and OGTT
postprandial glucose
Time frame: T=90 min postprandial
Bloood will be collected fasted and after intake of the MTT and OGTT
postprandial glucose
Time frame: T=120 min postprandial
Bloood will be collected fasted and after intake of the MTT and OGTT
fasting and postprandial glucose
Time frame: AUC and postprandial curve
Bloood will be collected fasted and after intake of the MTT and OGTT
fasting insulin
Time frame: T=0 min, before intake of test drink
Blood will be collected fasted and after intake of the MTT and OGTT
postprandial insulin
Time frame: T=10 min postprandial
Blood will be collected fasted and after intake of the MTT and OGTT
postprandial insulin
Time frame: T=20 min postprandial
Blood will be collected fasted and after intake of the MTT and OGTT
postprandial insulin
Time frame: T=30 min postprandial
Blood will be collected fasted and after intake of the MTT and OGTT
postprandial insulin
Time frame: T=45 min postprandial
Blood will be collected fasted and after intake of the MTT and OGTT
postprandial insulin
Time frame: T=60 min postprandial
Blood will be collected fasted and after intake of the MTT and OGTT
postprandial insulin
Time frame: T=90 min postprandial
Blood will be collected fasted and after intake of the MTT and OGTT
postprandial insulin
Time frame: T=120 min postprandial
Blood will be collected fasted and after intake of the MTT and OGTT
fasting and postprandial insulin
Time frame: AUC and postprandial curve
Blood will be collected fasted and after intake of the MTT and OGTT
14 secondary outcomes
Triglycerides
Time frame: T=0 min, before intake of test drink
Total cholesterol
Time frame: T=0 min, before intake of test drink
HDL-cholesterol
Time frame: T=0 min, before intake of test drink
Free fatty acids
Time frame: T=0 min, before intake of test drink
Hba1c
Time frame: T=0 min, before intake of test drink
Fasting stable glucose isotopes
Time frame: T=0, before intake of test drink
postprandial stable glucose isotopes
Time frame: T=10 min postprandial
postprandial stable glucose isotopes
Time frame: T=20 min postprandial
postprandial stable glucose isotopes
Time frame: T=30 min postprandial
postprandial stable glucose isotopes
Time frame: T=45 min postprandial
postprandial stable glucose isotopes
Time frame: T=60 min postprandial
postprandial stable glucose isotopes
Time frame: T=90 min postprandial
postprandial stable glucose isotopes
Time frame: T=120 min postprandial
fasting and postprandial stable glucose isotopes
Time frame: AUC and postprandial curve
Results and safety
The study was stopped early (reason given: slow recruitment, reached sufficient recruitment numbers for exploratory analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Background: PubMed 27121958Koning SH, Hoogenberg K, Lutgers HL, van den Berg PP, Wolffenbuttel BH. Gestational Diabetes Mellitus:current knowledge and unmet needs. J Diabetes. 2016 Nov;8(6):770-781. doi: 10.1111/1753-0407.12422. Epub 2016 Jul 28.
- Background: PubMed 27913848Venkataraman H, Ram U, Craik S, Arungunasekaran A, Seshadri S, Saravanan P. Increased fetal adiposity prior to diagnosis of gestational diabetes in South Asians: more evidence for the 'thin-fat' baby. Diabetologia. 2017 Mar;60(3):399-405. doi: 10.1007/s00125-016-4166-2. Epub 2016 Dec 2.
- BackgroundWorld Health Organization. World health statistics 2016: Monitoring health for the SDGs sustainable development goals. World Health Organization; 2016.
- Background: PubMed 9463740Ko GT, Chan JC, Woo J, Lau E, Yeung VT, Chow CC, Cockram CS. The reproducibility and usefulness of the oral glucose tolerance test in screening for diabetes and other cardiovascular risk factors. Ann Clin Biochem. 1998 Jan;35 ( Pt 1):62-7. doi: 10.1177/000456329803500107.
- Background: PubMed 14581157Maegawa Y, Sugiyama T, Kusaka H, Mitao M, Toyoda N. Screening tests for gestational diabetes in Japan in the 1st and 2nd trimester of pregnancy. Diabetes Res Clin Pract. 2003 Oct;62(1):47-53. doi: 10.1016/s0168-8227(03)00146-3.
- Background: PubMed 18249458Seshiah V, Cynthia A, Balaji V, Balaji MS, Ashalata S, Sheela R, Thamizharasi M, Arthi T. Detection and care of women with gestational diabetes mellitus from early weeks of pregnancy results in birth weight of newborn babies appropriate for gestational age. Diabetes Res Clin Pract. 2008 May;80(2):199-202. doi: 10.1016/j.diabres.2007.12.008. Epub 2008 Feb 4.
- Background: PubMed 18463375HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
- Background: PubMed 29029897NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in body-mass index, underweight, overweight, and obesity from 1975 to 2016: a pooled analysis of 2416 population-based measurement studies in 128.9 million children, adolescents, and adults. Lancet. 2017 Dec 16;390(10113):2627-2642. doi: 10.1016/S0140-6736(17)32129-3. Epub 2017 Oct 10.
- Background: PubMed 30092099Chen C, Xu X, Yan Y. Estimated global overweight and obesity burden in pregnant women based on panel data model. PLoS One. 2018 Aug 9;13(8):e0202183. doi: 10.1371/journal.pone.0202183. eCollection 2018.
- Background: PubMed 16827826Catalano PM, Ehrenberg HM. The short- and long-term implications of maternal obesity on the mother and her offspring. BJOG. 2006 Oct;113(10):1126-33. doi: 10.1111/j.1471-0528.2006.00989.x. Epub 2006 Jul 7.
- Background: PubMed 26742932Zhu Y, Zhang C. Prevalence of Gestational Diabetes and Risk of Progression to Type 2 Diabetes: a Global Perspective. Curr Diab Rep. 2016 Jan;16(1):7. doi: 10.1007/s11892-015-0699-x.
- Background: PubMed 29167927Koning SH, van Zanden JJ, Hoogenberg K, Lutgers HL, Klomp AW, Korteweg FJ, van Loon AJ, Wolffenbuttel BHR, van den Berg PP. New diagnostic criteria for gestational diabetes mellitus and their impact on the number of diagnoses and pregnancy outcomes. Diabetologia. 2018 Apr;61(4):800-809. doi: 10.1007/s00125-017-4506-x. Epub 2017 Nov 22.
- Individual participant dataSharing planned: Yes. The study protocol will be submitted for publication in a peer reviewed journal
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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.
Eline M van der Beek, Prof. Dr. principal investigator
University Medical Center Groningen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes and Other "Heavy-For-Dates" Infants, run by University Medical Center Groningen at 2 sites in Netherlands.
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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 30 Mar 2025. 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 Netherlands. 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 was stopped early (reason given: slow recruitment, reached sufficient recruitment numbers for exploratory analysis). 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?
fasting glucose (time frame: T=0 min, before intake of test drink). The study lists 18 primary outcomes in all. 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 NCT04315545, which also lists 27 linked publications.
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 Mar 2025.