Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Circadian Rhythm and Metabolic Effects of Exercise (HITMet)

11. november 2021 opdateret af: Harriet Wallberg, Karolinska Institutet

Time of Day Specific Glycaemic and Metabolic Response to High-Intensity Interval Training

Physical exercise is efficacious in controlling blood glucose levels in individuals with Type 2 diabetes. An individual's exercise capacity and ability to utilize glucose as an energy source oscillates throughout the day. Hence, the beneficial effects of exercise on blood glucose levels may depend on the time of day when the exercise bout is performed. However, the time of day in which the most beneficial adaptations to exercise can be achieved remains unknown. This project aims to answer the following questions: Does time of day impact the beneficial effects of exercise on blood glucose? If so, when can the most beneficial effects of exercise be achieved? Which metabolic mechanisms links time of day, exercise and blood glucose control? To address these questions, individuals with or without Type 2 diabetes will perform an exercise session at two different times (09:00 and 16:00), and continuous glucose monitoring will be used to assess the effects of exercise on blood glucose. We will determine the specific metabolic processes which promote the most beneficial blood glucose response. To achieve this, we will measure which metabolic substrates (carbohydrates, lipids and proteins) are used and which metabolites produced in blood, skeletal muscle and adipose tissue in response to exercise at different times of the day.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Exercise has well-established metabolic benefits and is a preferred intervention for Type 2 diabetes prevention and management. Metabolic determinants of exercise such as skeletal muscle and whole-body substrate oxidation capacity, glucose tolerance and insulin sensitivity and adipose tissue fatty acid release all show circadian oscillations. These rhythms may promote substantially different responses depending on the time of day when exercise is performed.

This is an exploratory study aiming to determine whether exercise at specific times of day can amplify the beneficial effects on glycemia and metabolism in twi groups of individuals: those with normal glucose tolerance (NGT) or Type 2 diabetes (n=40 per group). The primary objective is to determine the glycemic response to an exercise bout at two distinct times of day, measured by continuous glucose monitoring, in men and women with NGT or Type 2 diabetes. The secondary aim is to identify specific metabolites which facilitate the strongest glycemic response to exercise by examining the whole-body and peripheral tissue metabolomic response to an exercise bout.

The primary goal of the study is to examine the glycemic and metabolic response to exercise within-group for participants with NGT or Type 2 diabetes. Further comparisons will be made between groups with NGT or Type 2 diabetes, across sexes, and by individual chronotype (determined by a standardized questionnaire) to examine the variation in the exercise response across these parameters.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Sverige
      • Stockholm, Sverige, 17070
        • Rekruttering
        • Karolinska Institutet
        • Kontakt:
        • Ledende efterforsker:
          • Harriet Wallberg-Henriksson, MD PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

45 år til 68 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Body Mass Index (BMI): 23 - 33 kg/m2
  • Participants diagnosed with Type 2 Diabetes (insulin independent) or Normal Glucose Tolerant (2h oral glucose tolerance test within normal range).
  • Ability to provide informed consent
  • Ability to complete the exercise regiment

Exclusion Criteria:

  • Medications: Insulin
  • Current nicotine user (cigarettes, snus, nicotine gum) or past nicotine users less than 6 months before inclusion in the study
  • Pre-existing cardiovascular condition (Angina pectoris, Cardiac arrhythmia, Cardiac infarction, Coronary stent / angiography, Cerebrovascular insult, Hypertension [> 160 mmHg systolic, or > 95 mmHg diastolic])
  • Pre-existing blood-borne disease (HIV, Hepatitis C, MRSA)
  • Pre-existing systemic or localized rheumatic illness
  • Malignant Disease
  • Pre-existing psychiatric disorder
  • Another pre-existing systemic disease

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Morning First
Participants will complete a single bout of exercise at 09:00, and after at least a one-week washout perform another exercise bout at 16:00.
Adfærdsmæssigt: High-intensity Intermittent Exercise
The participants will perform a low-volume, High-intensity Intermittent Exercise bout on a cycle ergometer. Peak exercise capacity of the study participants will be determined on a separate occasion using a ramp-up maximal oxygen consumption test (VO2peak). A single exercise bout will consist of a 7-minute warm-up on a cycle ergometer, followed by 6 1-minute intervals of cycling at individual maximal capacity and 75rpm (rotations per minute). These intervals will be interspersed with 1-min breaks of cycling at low resistance and 75rpm, and the session will conclude with a 3-minute cool-down interval (20 minutes in total).
Eksperimentel: Afternoon First
Participants will complete a single bout of exercise at 16:00, and after at least a one-week washout perform another exercise bout at 09:00.
Adfærdsmæssigt: High-intensity Intermittent Exercise
The participants will perform a low-volume, High-intensity Intermittent Exercise bout on a cycle ergometer. Peak exercise capacity of the study participants will be determined on a separate occasion using a ramp-up maximal oxygen consumption test (VO2peak). A single exercise bout will consist of a 7-minute warm-up on a cycle ergometer, followed by 6 1-minute intervals of cycling at individual maximal capacity and 75rpm (rotations per minute). These intervals will be interspersed with 1-min breaks of cycling at low resistance and 75rpm, and the session will conclude with a 3-minute cool-down interval (20 minutes in total).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Exercise-induced Changes in 24 Hour Interstitial Glucose Concentration
Tidsramme: 3 days (1 day before to 1 day after exercise)
Glucose excursions will be charted using continuous interstitial glucose monitors. The day immediately before exercise will be used as baseline, the day of exercise to assess the acute response, and the day after exercise to assess lasting effects on glycemia. Exercise effects on glucose concentration will be primarily assessed by comparing 24-hour curves between conditions.
3 days (1 day before to 1 day after exercise)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acute Exercise-induced Changes in Interstitial Glucose Concentration
Tidsramme: 2 hours (0 minutes before to 120 minutes after exercise)
Glucose will be charted using continuous glucose monitors. Acute response to exercise, during the exercise bout and during an additional 120 minutes will be compared between conditions.
2 hours (0 minutes before to 120 minutes after exercise)
Interstitial Glucose Concentration Response to a Meal
Tidsramme: 2 days (1 day before and day of exercise)
Glucose will be charted using continuous glucose monitors. Three standardized meals per day will be provided on each occasion for the day before, day of and day after exercise. The 120 minute glucose response to the standardized meal succeeding an exercise bout will be compared to the same meal on a baseline (no exercise) day and between the two exercise times.
2 days (1 day before and day of exercise)
Interstitial Glucose Concentration Variability
Tidsramme: 3 days (1 day before to 1 day after exercise)
Glucose will be charted using continuous glucose monitors. The day immediately before exercise will be used as baseline, the day of exercise to assess the acute response, and the day after exercise to assess lasting effects on glucose concentration variability.
3 days (1 day before to 1 day after exercise)
Time Spent in Interstitial Glucose Concentration Range
Tidsramme: 3 days (1 day before to 1 day after exercise)
Glucose will be charted using continuous glucose monitors. The day immediately before exercise will be used as baseline, the day of exercise to assess the acute response, and the day after exercise to assess lasting effects on glycemic variability. Daily time spent in low (<3.9mmol/L), high (>10mmol/L) and within target glycemic range (3.9-10mmol/L) will be calculated on each occasion.
3 days (1 day before to 1 day after exercise)
Nocturnal Interestitial Glucose Concentration
Tidsramme: 2 days (day of, and 1 day after exercise)
Glucose will be charted using continuous glucose monitors. The day immediately before exercise will be used as baseline, the day of exercise to assess the acute response, and the day after exercise to assess lasting effects on glycemic variability. Nocturnal glycemia (00:00-06:00) for each day will be compared on each exercise occasion.
2 days (day of, and 1 day after exercise)
Metabolic Response to Exercise
Tidsramme: 1 hour (5 minutes before, 5 minutes after and 60 minutes after exercise)
Changes in blood, skeletal muscle and subcutaneous adipose tissue metabolite levels will be assessed by broad-spectrum, untargeted metabolomics. Samples will be collected immediately before (-5 minutes) and after (+5 minutes) each exercise bout. An additional blood sample will be collected one hour after exercise completion (+60 minutes).
1 hour (5 minutes before, 5 minutes after and 60 minutes after exercise)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Karolinska Institutet

Samarbejdspartnere

Karolinska University Hospital

Efterforskere

  • Ledende efterforsker: Harriet Wallberg-Henriksson, MD PhD, Karolinska Institutet

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. november 2021

Primær færdiggørelse (Forventet)

1. november 2023

Studieafslutning (Forventet)

1. november 2023

Datoer for studieregistrering

Først indsendt

19. oktober 2021

Først indsendt, der opfyldte QC-kriterier

1. november 2021

Først opslået (Faktiske)

10. november 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. november 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. november 2021

Sidst verificeret

1. november 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HIT Metabolome

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

Individual participant data underlying results reported in a publication will be shared after deidentification.

IPD-delingstidsramme

Data will be made available indefinetly after publication.

IPD-delingsadgangskriterier

Data will be available for any purpose.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Diabetes mellitus, type 2

Kliniske forsøg med High-intensity Intermittent Exercise

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in United Arab Emirates

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner