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

28. april 2026 oppdatert av: 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.

Studieoversikt

Status

Påmelding etter invitasjon

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

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).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Women with previous gestational diabetes mellitus
Women with previous gestational diabetes mellitus, aged 25-45, who gave birth 2-8 years ago.
Annen: 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.
Aktiv komparator: Women without previous gestational diabetes
Women without previous gestational diabetes mellitus, aged 25-45, who gave birth 2-8 years ago.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
β-cell function by OGTT
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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))
Tidsramme: 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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Plasma-specific metabolomics by LC- and GC-MS
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Lipid profile
Tidsramme: 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
Tidsramme: At examination day 2 and 4.
Determined by blood tests.
At examination day 2 and 4.
Insulin
Tidsramme: At examination day 2 and 4.
Determined by blood tests.
At examination day 2 and 4.
Glucose
Tidsramme: At examination day 2 and 4.
Determined by blood tests.
At examination day 2 and 4.
C-peptide
Tidsramme: At examination day 2 and 4.
Determined by blood tests.
At examination day 2 and 4.
Levels of systemic low-grade inflammation
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Odense University Hospital

Samarbeidspartnere

University of Southern Denmark

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

13. mars 2026

Primær fullføring (Antatt)

1. januar 2028

Studiet fullført (Antatt)

1. november 2028

Datoer for studieregistrering

Først innsendt

26. februar 2026

Først innsendt som oppfylte QC-kriteriene

28. april 2026

Først lagt ut (Faktiske)

5. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 25/55674

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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