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

28 kwietnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rejestracja na zaproszenie

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

40

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Women with previous gestational diabetes mellitus
Women with previous gestational diabetes mellitus, aged 25-45, who gave birth 2-8 years ago.
Inny: 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.
Aktywny komparator: Women without previous gestational diabetes
Women without previous gestational diabetes mellitus, aged 25-45, who gave birth 2-8 years ago.
Inny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
β-cell function by OGTT
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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))
Ramy czasowe: 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
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Plasma-specific metabolomics by LC- and GC-MS
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Lipid profile
Ramy czasowe: 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
Ramy czasowe: At examination day 2 and 4.
Determined by blood tests.
At examination day 2 and 4.
Insulin
Ramy czasowe: At examination day 2 and 4.
Determined by blood tests.
At examination day 2 and 4.
Glucose
Ramy czasowe: At examination day 2 and 4.
Determined by blood tests.
At examination day 2 and 4.
C-peptide
Ramy czasowe: At examination day 2 and 4.
Determined by blood tests.
At examination day 2 and 4.
Levels of systemic low-grade inflammation
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Odense University Hospital

Współpracownicy

University of Southern Denmark

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

13 marca 2026

Zakończenie podstawowe (Szacowany)

1 stycznia 2028

Ukończenie studiów (Szacowany)

1 listopada 2028

Daty rejestracji na studia

Pierwszy przesłany

26 lutego 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

28 kwietnia 2026

Pierwszy wysłany (Rzeczywisty)

5 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

5 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

28 kwietnia 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 25/55674

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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