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Women With Previous GDM and the Effects of HIIT. (GDM-HIIT)

28 avril 2026 mis à jour par: Odense University Hospital

Deep Metabolic and Molecular Phenotyping of Women With Previous Gestational Diabetes Mellitus and the Responses to High-intensity Interval Training.

The goal of this clinical trial is to investigate if women with previous gestational diabetes (pGDM) are characterized with unique metabolic and molecular alterations compared to women without pGDM. Furthermore if 8 weeks of high-intensity interval training (HIIT) can improve these alterations. The main questions we aim to answer are:

  1. Women with pGDM have metabolic abnormalities compared with women without pGDM, and that these metabolic abnormalities are explained by unique molecular abnormalities in skeletal muscle and adipose tissue.
  2. Eight weeks of HIIT combining rowing and cycling can markedly improve these metabolic abnormalities in women with pGDM and these improvements are explained by beneficial cellular and molecular changes in skeletal muscle and adipose tissue.

Researchers will compare 20 women with pGDM to 20 glucosetolerant without pGDM, who are matched on age, BMI and times since last pregnancy.

Participants will undergo a screening visit and examinations on two separate days before (day 1 and day 2) and two separate days after (day 3 and day 4) 8-weeks of HIIT, in all cases after an overnight fast (≥ 12 h). Day 1 and day 3 will include assessment of body composition and VO2max. On day 2 and day 4, the insulin sensitivity, substrate metabolism, and β-cell function of the participants will be examined by a Botnia-clamp combined by indirect calorimetry. Skeletal muscle biopsies from m. vastus lateralis and subcutaneous abdominal adipose tissue biopsies are taken in the basal and insulin-stimulated states of each clamp.

Aperçu de l'étude

Statut

Inscription sur invitation

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

40

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Danemark
    • Region Syddanmark
      • Odense, Region Syddanmark, Danemark, 5000
        • Steno Diabetes Center Odense, Odense University Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Oui

La description

Inclusion Criteria:

  • Age 25-45 years
  • BMI 20-35 kg/m2
  • 2-8 years since the last pregnancy
  • No known diabetes or PCOS
  • No previous bariatric surgery
  • No known disease
  • Be drug-naive
  • Have a regular menstrual cycle (23-35 days)
  • Not be pregnant or planning pregnancy during the study period
  • Low or moderate level of physical activity must be (max 2 hours of moderate exercise weekly).
  • All participants should be able to provide informed consent
  • Women without pGDM must not have known hypertension or first-degree relatives with diabetes.

Exclusion Criteria:

  • Abnormal cardiac stethoscopy, ECG or screening blood tests
  • Positive plasma GAD-65 antibodies
  • Positive plasma choriogonadotropine
  • Undiagnosed T2D based on fasting plasma glucose (≥ 7.0 mmol/mol), plasma HbA1c (≥ 48 mmol/mol), or 2-h plasma glucose during an oral glucose tolerance test (OGTT) (≥ 11.1 mmol/mol)
  • Dyslipidemia (plasma LDL-cholesterol > 5.0 mmol/l)
  • In women with pGDM: Undiagnosed severe hypertension (blood pressure > 160/100)
  • In women without pGDM: Undiagnosed hypertension (blood pressure >140/90 mmHg) or impaired glucose tolerance (fasting plasma glucose at 6.16.9 mmol/l, plasma HbA1c at 42-47 mmol/mol, or a 2-h glucose at 7.8-11.0 mmol/l during an OGTT).

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Women with previous gestational diabetes mellitus
Women with previous gestational diabetes mellitus, aged 25-45, who gave birth 2-8 years ago.
Autre: High-intensity interval training
The training intervention consists of 8-weeks of HIIT combining rowing and cycling on ergometers with two supervised sessions weekly in small groups of up to 10 participants. All HIIT sessions will start with a 10-min warm-up period followed by training blocks of 5 x 1 min high-intensity intervals (100-110% of Wattmax corresponding to ≥ 85% of maximum heart rate (HRmax)) each interspersed by 1 min active or resting recovery. Between the training blocks, the participants will have a 4-min break in which they shift from cycling to rowing or vice versa. The number of training blocks will gradually increase from two to five blocks during the 8-week intervention period with one block being added every second week. Halfway through the HIIT-protocol the workload will be adjusted according to a midway VO2max test. Participants will wear a heart monitor during training sessions.
Comparateur actif: Women without previous gestational diabetes
Women without previous gestational diabetes mellitus, aged 25-45, who gave birth 2-8 years ago.
Autre: High-intensity interval training
The training intervention consists of 8-weeks of HIIT combining rowing and cycling on ergometers with two supervised sessions weekly in small groups of up to 10 participants. All HIIT sessions will start with a 10-min warm-up period followed by training blocks of 5 x 1 min high-intensity intervals (100-110% of Wattmax corresponding to ≥ 85% of maximum heart rate (HRmax)) each interspersed by 1 min active or resting recovery. Between the training blocks, the participants will have a 4-min break in which they shift from cycling to rowing or vice versa. The number of training blocks will gradually increase from two to five blocks during the 8-week intervention period with one block being added every second week. Halfway through the HIIT-protocol the workload will be adjusted according to a midway VO2max test. Participants will wear a heart monitor during training sessions.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
β-cell function by OGTT
Délai: At screening visit.
Will be estimated as the disposition index (DI) by oral glucose tolerance test (OGTT) derived indices of insulin sensitivity and insulin secretion, after a 2-hour OGTT (75g) with measurement of plasma glucose, serum insulin and serum C-peptide at 0, 30 and 120 min.
At screening visit.
β-cell function by Botnia-clamp
Délai: At examination day 2 and 4.
β-cell function adjusted for insulin sensitivity will be determined by calculating the DI as a product of the acute insulin response to glucose (AIRg) and insulin-stimulated glucose infusion rate (GIR).
At examination day 2 and 4.
Whole body composition (lean body mass and fat mass)
Délai: At examination day 1 and 3.
Will be obtained by a dual-energy X-ray absorptiometry (DXA) scanning (Prodigy Advance, GE Healthcare, CHI, US)
At examination day 1 and 3.
Lean body mass
Délai: At examination day 1 and 3.
Will be obtained by a dual-energy X-ray absorptiometry (DXA) scanning (Prodigy Advance, GE Healthcare, CHI, US)
At examination day 1 and 3.
Fat mass
Délai: At examination day 1 and 3.
Will be obtained by a dual-energy X-ray absorptiometry (DXA) scanning (Prodigy Advance, GE Healthcare, CHI, US)
At examination day 1 and 3.
Cardiorespiratory fitness (maximal oxygen consumptions (VO2-max))
Délai: At examination day 1 and 3.
Will be determined by an incremental exercise test on a cycle ergometer (SRM Ergometer System, Jülich, DE) combined with mixed chamber cardiopulmonary exercise analyzer (Oxigraf, Model O2CPX, California, US)
At examination day 1 and 3.
Insulin sensitivity by Botnia-clamp
Délai: At examination day 2 and 4.
Consisting of a hyperinsulinemic-euglycemic clamp (insulin 40mU/min/m2 for 3 h) combined with a 60 min intravenous glucose tolerance test (IVGGT) using a glucose bolus (0.3 kg per kg body weight with a maximum of 25 g glucose).
At examination day 2 and 4.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Plasma-specific metabolomics by LC- and GC-MS
Délai: At examination day 2 and 4.
Liquid chromatography (LC)- and gas chromatography (GS)-based mass spectrometry (MS) will be used to detection, identification, and quantitation of very large numbers of metabolites in the micro- and nano-molar range in body fluids, such as blood.
At examination day 2 and 4.
Tissue-specific metabolomics by LC- and GC-MS
Délai: At examination day 2 and 4.
Liquid chromatography (LC)- and gas chromatography (GS)-based mass spectrometry (MS) will be used to detection, identification, and quantitation of very large numbers of metabolites in the micro- and nano-molar range in body tissues.
At examination day 2 and 4.
Proteomics
Délai: At examination day 2 and 4.
To identify biological processes and signaling networks altered in women with pGDM and changed in response to HIIT, we will apply unbiased mass-spectrometry based proteome analysis of the skeletal muscle and adipose tissue biopsies.
At examination day 2 and 4.
Phosphoproteomics
Délai: At examination day 2 and 4.
To identify biological processes and signaling networks altered in women with pGDM and changed in response to HIIT, we will apply unbiased mass-spectrometry based phosphoproteome analysis of the skeletal muscle and adipose tissue biopsies.
At examination day 2 and 4.
Transcriptional profiling and gene expression
Délai: At examination day 2 and 4.

High-resolution transcriptional profiling of abdominal adipose tissue and skeletal muscle biopsies will be performed using total RNA sequencing with next generation sequencing (TruSeq® Stranded Total RNA Library Prep Gold; Illumina).

Gene expressions are quantified using Targeted quantitative real-time PCR (qRT-PCR) and Western Blotting.
At examination day 2 and 4.
Mitochondrial respiration
Délai: At examination day 2 and 4.
Will be measured on permeabilized muscle fibers, and analyzed by measuring oxygen consumption when adding substrates, uncouplers, and inhibitors to the chambers of a high-resolution oxygraphy.
At examination day 2 and 4.
Lipid droplets by TEM
Délai: At examination day 2 and 4.
The morphology, volume, and localization of lipid droplets in muscle biopsies from the study cohorts will be determined by Transmission Electron Microscopy (TEM).
At examination day 2 and 4.
Mitochondria by TEM
Délai: At examination day 2 and 4.
The morphology, volume, and localization of mitochondria in muscle biopsies from the study cohorts will be determined by Transmission Electron Microscopy (TEM).
At examination day 2 and 4.
Lipid droplet interaction with mitochondria by TEM
Délai: At examination day 2 and 4.
The the physical interaction between lipid droplets and mitochondria in muscle biopsies from the study cohorts will be determined by Transmission Electron Microscopy (TEM).
At examination day 2 and 4.
Protein abundance
Délai: At examination day 2 and 4.
Protein abundance will be studied in skeletal muscle and adipose tissue biopsies by Western blotting procedures.
At examination day 2 and 4.
Phosphorylation of enzymes
Délai: At examination day 2 and 4.
Phosphorylation of enzymes will be studied in skeletal muscle and adipose tissue biopsies by Western blotting procedures.
At examination day 2 and 4.

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Lipid profile
Délai: At examination day 2 and 4.
Plasma total cholesterol, HDL-cholesterol, LDL-cholesterol, non-HDL-cholesterol and triglycerides determined by blood tests.
At examination day 2 and 4.
HbA1c
Délai: At examination day 2 and 4.
Determined by blood tests.
At examination day 2 and 4.
Insulin
Délai: At examination day 2 and 4.
Determined by blood tests.
At examination day 2 and 4.
Glucose
Délai: At examination day 2 and 4.
Determined by blood tests.
At examination day 2 and 4.
C-peptide
Délai: At examination day 2 and 4.
Determined by blood tests.
At examination day 2 and 4.
Levels of systemic low-grade inflammation
Délai: At examination day 2 and 4.
Circulating levels of adiponectin, leptin, interleukin-6 (IL-6), fibroblast growth factor 21 (FGF21), angiopoietin-like 4 (ANGPTL4) and growth differentiation factor 15 (GDF15) will be measured in bloodsamples.
At examination day 2 and 4.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Odense University Hospital

Collaborateurs

University of Southern Denmark

Les enquêteurs

  • Chercheur principal: Kurt Højlund, Prof. Dr. med., Steno Diabetes Center Odense, Odense University Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

13 mars 2026

Achèvement primaire (Estimé)

1 janvier 2028

Achèvement de l'étude (Estimé)

1 novembre 2028

Dates d'inscription aux études

Première soumission

26 février 2026

Première soumission répondant aux critères de contrôle qualité

28 avril 2026

Première publication (Réel)

5 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 avril 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 25/55674

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Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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