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PRegnancy Outcomes and Maternal Insulin Sensitivity

PRegnancy Outcomes and Maternal Insulin Sensitivity - PROMIS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48381
Enrollment
130
Registered
2019-07-18
Start date
2020-02-06
Completion date
Unknown
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational diabetes mellitus pregnancy diabetes

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Healthy singleton pregnant women (10-12 weeks of gestation) - BMI >=25 kg/m2 - Fasting Blood Glucose (FBG

Exclusion criteria

Exclusion criteria: - 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 FBG >=7.0 mmol/l or use of diabetes medication - Participation in any other studies involving the investigation of medication or nutritional products 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 nutritional ingredients in the MTT - Psychological dysfunctions

Design outcomes

Primary

MeasureTime frame
-Fasting levels of: glucose and insulin -PP responses of: glucose and insulin collected at t=0,10, 20,30,45,60,90 and 120 min after the MTT or OGTT.

Secondary

MeasureTime frame
Secondary study parameters: - fasting levels of total cholesterol, high density lipoprotein (HDL), triglycerides, free fatty acids, HbA1c, human placental lactogen, leptin, and cortisol. - Maternal anthropometrics and adiposity measures - Fetal growth and adiposity sonography measures - Neonatal growth and adiposity measures - Maternal, fetal and neonatal complications Exploratory sudy parameters: - fasting and postprandial levels of stable glucose isotopes - neonatal eating behaviour - Lifestyle questionnaires

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)