Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

28 april 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Aanmelden op uitnodiging

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Women with previous gestational diabetes mellitus
Women with previous gestational diabetes mellitus, aged 25-45, who gave birth 2-8 years ago.
Ander: 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.
Actieve vergelijker: Women without previous gestational diabetes
Women without previous gestational diabetes mellitus, aged 25-45, who gave birth 2-8 years ago.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
β-cell function by OGTT
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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))
Tijdsspanne: 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
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Plasma-specific metabolomics by LC- and GC-MS
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Lipid profile
Tijdsspanne: 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
Tijdsspanne: At examination day 2 and 4.
Determined by blood tests.
At examination day 2 and 4.
Insulin
Tijdsspanne: At examination day 2 and 4.
Determined by blood tests.
At examination day 2 and 4.
Glucose
Tijdsspanne: At examination day 2 and 4.
Determined by blood tests.
At examination day 2 and 4.
C-peptide
Tijdsspanne: At examination day 2 and 4.
Determined by blood tests.
At examination day 2 and 4.
Levels of systemic low-grade inflammation
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Odense University Hospital

Medewerkers

University of Southern Denmark

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

13 maart 2026

Primaire voltooiing (Geschat)

1 januari 2028

Studie voltooiing (Geschat)

1 november 2028

Studieregistratiedata

Eerst ingediend

26 februari 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 april 2026

Eerst geplaatst (Werkelijk)

5 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

28 april 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 25/55674

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Diabetes type 2 (T2DM)

Klinische onderzoeken op High-intensity interval training

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Taiwan

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

Abonneren