Pregnancy Outcomes and Maternal Insulin Sensitivity

NCT04315545 | Terminated DMC

• 1 other identifier: 68845
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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. 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.

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; neonatal health; maternal health; maternal insulin sensitivity; gestational weight gain; diagnostic tool; early screening; prevention; overweight; obesitiy; metabolic health; neonatal adiposity; maternal adiposity

Outcome Measures

Primary Outcomes (18)

• fasting glucose

  Bloood will be collected fasted and after intake of the MTT and OGTT

  T=0 min, before intake of test drink

• postprandial glucose

  Bloood will be collected fasted and after intake of the MTT and OGTT

  T=10 min postprandial

• postprandial glucose

  Bloood will be collected fasted and after intake of the MTT and OGTT

  T=20 min postprandial

• postprandial glucose

  Bloood will be collected fasted and after intake of the MTT and OGTT

  T=30 min postprandial

• postprandial glucose

  Bloood will be collected fasted and after intake of the MTT and OGTT

  T=45 min postprandial

• postprandial glucose

  Bloood will be collected fasted and after intake of the MTT and OGTT

  T=60 min postprandial

• postprandial glucose

  Bloood will be collected fasted and after intake of the MTT and OGTT

  T=90 min postprandial

• postprandial glucose

  Bloood will be collected fasted and after intake of the MTT and OGTT

  T=120 min postprandial

• fasting and postprandial glucose

  Bloood will be collected fasted and after intake of the MTT and OGTT

  AUC and postprandial curve

• fasting insulin

  Blood will be collected fasted and after intake of the MTT and OGTT

  T=0 min, before intake of test drink

• postprandial insulin

  Blood will be collected fasted and after intake of the MTT and OGTT

  T=10 min postprandial

• postprandial insulin

  Blood will be collected fasted and after intake of the MTT and OGTT

  T=20 min postprandial

• postprandial insulin

  Blood will be collected fasted and after intake of the MTT and OGTT

  T=30 min postprandial

• postprandial insulin

  Blood will be collected fasted and after intake of the MTT and OGTT

  T=45 min postprandial

• postprandial insulin

  Blood will be collected fasted and after intake of the MTT and OGTT

  T=60 min postprandial

• postprandial insulin

  Blood will be collected fasted and after intake of the MTT and OGTT

  T=90 min postprandial

• postprandial insulin

  Blood will be collected fasted and after intake of the MTT and OGTT

  T=120 min postprandial

• fasting and postprandial insulin

  Blood will be collected fasted and after intake of the MTT and OGTT

  AUC and postprandial curve

Secondary Outcomes (14)

• Triglycerides

  T=0 min, before intake of test drink

• Total cholesterol

  T=0 min, before intake of test drink

• HDL-cholesterol

  T=0 min, before intake of test drink

• Free fatty acids

  T=0 min, before intake of test drink

• Hba1c

  T=0 min, before intake of test drink

Other Outcomes (20)

• FFQ

  between week 12-16 of gestation

• FFQ

  between 24-28 of gestation

• FFQ

  1 month postpartum

Study Arms (1)

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.

Diagnostic Test: meal tolerance test

Interventions

meal tolerance test DIAGNOSTIC_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.

Healthy women pregnant of singleton with a BMI ≥25 kg/m2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (2)

University Medical Centre Groningen

Groningen, 9713 GZ, Netherlands

Location

Medical Center Leeuwarden

Leeuwarden, 8984 AD, Netherlands

Location

Related Publications (26)

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  BACKGROUND

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  PMID: 18249458 BACKGROUND

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  PMID: 26742932 BACKGROUND

• Koning 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.

  PMID: 29167927 BACKGROUND

• Koning 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.

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Biospecimen

Retention: SAMPLES WITHOUT DNA

serum \& plasma samples

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus, Type 2; Insulin Resistance; Gestational Weight Gain; Overweight

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders

Study Officials

• Eline M van der Beek, Prof. Dr.

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. E.M. van der Beek

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: March 19, 2020
• Study Start: February 6, 2020
• Primary Completion: July 8, 2024
• Study Completion: July 8, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2021 PROMIS design and study rationale published in Journal of Clinical Medicine
• Access Criteria: access to detailed information by others will be subject to evaluation by the PI and project team, based on submission of an official request with details on what, why and how.

Locations

NL (2)