Prevention of Gestational Diabetes

NCT04028089 | Unknown

• 1 other identifier: 104/2019BO1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Pregnancy is a vulnerable period for both a mother and her developing child. The investigator hypothesizes that diet-induced glucose excursions in the pregnant mother are a key contributor to unfavourable brain development and epigenetic marks in the developing child. It is long known that metabolic conditions are influenced by maternal nutrition and that this can impact the unborn infant. The most prominent example is gestational diabetes (GDM). It is unclear at what point unfavourable changes in brain development occur during pregnancy. Unlike many previous trials, we plan to introduce healthy diet early in the first trimester. Comparative analyses of DNA methylation patterns in the offspring of women with or without GDM revealed preferentially methylated genes, particularly in pathways linked to metabolic diseases. NuPreGDM is a randomized, controlled, open label intervention trail. The investigator aims to assess the effect of individual diet counselling combined with CGM compared to regular diet on glucose levels and postprandial glycemic excursions during an OGTT in pregnancy. The investigator wants to assess the effect of dietary counselling combined with continuous glucose monitoring on GDM risk, glycaemia and pregnancy outcome, starting in the first trimester. The investigator further hypothesizes that improved glucose levels by a healthy diet will affect brain activity of the infant and prevent unfavourable epigenetic modifications. The investigator plans to include 50 pregnant women within gestational week 4 and 14 after the last menstruation, with elevated risk for development of (GDM). Participants will be randomized 1:1 to either "diet modification group" (intervention) or to "standard diet group" (control). In the current trial, the investigator aims to modulate maternal metabolism with periodic personalized diet counselling on the basis of continuous glucose monitoring (CGM) compared to regular diet throughout pregnancy. The investigator propose that a reduction in glucose excursions in the mother will lead to a healthy environment for the developing child and prevent altered brain activity in utero, which will be assessed by fMEG (fetal magnetoencephalography) during a 75g OGTT in gestational week 28. The investigator further planned to examine child's leucocytes from cord blood to assess whether a healthy diet of the mother prevented epigenetic alterations due to improved maternal glycaemia, as exploratory endpoint. The development of blood sugar levels of the mother postpartum will be assessed by an further OGTT 6-12 weeks postpartum.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Glycaemic excursion during an oral glucose tolerance test

  The effect of a diet modification on glucose levels and postprandial glycemic excursions (AUC) during a 75g oral glucose tolerance test (OGTT) will be measured.

  gestational week (GW) 24 - 28

Secondary Outcomes (12)

• Glucose variability

  Gestational week 14,20, 28, 34 and one week postpartum

• Maternal weight gain during pregnancy

  Gestational week 14,20, 28, 34

• Maternal insulin sensitivity

  gestational week (GW) 24 - 28 and 6-12 weeks postpartum

• Maternal insulin secretion

  gestational week (GW) 24 - 28 and 6-12 weeks postpartum

• Fetal brain activity

  Gestational week 28

Other Outcomes (1)

• Epigenetic modification

  Delivery

Study Arms (2)

Diet Modification Group

EXPERIMENTAL

Behavioral: Diet Modification Group

Regular Diet Group

OTHER

Other: Regular Diet Group

Interventions

Diet Modification Group BEHAVIORAL

The diet modification group will receive diet counselling by an experienced dietician at least every four weeks throughout pregnancy starting in the first trimester. The dietary counselling will be guided by the individual glucose profiles obtained through flash glucose monitoring.

Diet Modification Group

Regular Diet Group OTHER

Participants of the "standard diet" will receive general diet counselling on one occasion at the onset of the study.

Regular Diet Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women between gestational week 4 and 14 after the last menstruation (proof of b-human choriongonadotropin in urine or proof of pregnancy via ultrasound.)
• Pre-pregnancy overweight (pregravid BMI \> = 27) or positive family history of type 2 diabetes or GDM in first-degree relatives or GDM in previous pregnancy or previous macrosomia (baby with birth weight \> 4000 g) or advanced maternal age \> = 40 years
• Ability to understand and voluntarily sign an informed consent document prior to any study related procedures.

You may not qualify if:

• Age \< 18 years
• Multiple pregnancy
• Pre-pregnancy Diabetes mellitus
• Treatment with drugs with central nervous actions
• Chronic alcohol disease and drug abuse
• Pre-existing cardiac condition
• Mental disorder
• Weight loss \>10% in the previous 6 months
• GFR \< 60 ml/min/1.73 m2
• fold increased transaminase levels in reference to the upper standard
• Any other (clinical) condition that would endanger participant's safety or question scientific success according to a physician's opinion.

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University of Tuebingen, Department of Internal Medicine IV

Tübingen, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 22, 2019
• Study Start: July 15, 2019
• Primary Completion: July 1, 2023
• Study Completion: November 1, 2023
• Last Updated: March 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)