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Impact of Physical Activity on Blood Glucose Stability and Energy Stores in Individuals With Type 1 Diabetes (CARBEX1)

9. august 2016 opdateret af: University Hospital Inselspital, Berne

Exercise-related Fuel Metabolism and Glucose Stability in Individuals With Type 1 Diabetes Mellitus

Whereas physical activity clearly results in improvements in glycemic control in type 2 diabetes, in individuals with type 1 diabetes (T1DM) the impact of exercise on blood sugar control is more complex. In type 1 diabetes T1DM the inability to reduce exogenous insulin levels during exercise is a key factor that contributes to an increased risk of exercise-induced hypoglycemia. Since rapid adaptation of insulin dosage may be especially difficult in patients on a multiple daily injection regimen, alternative strategies are required to improve exercise-associated glucose stability. There is increasing evidence that the combination of steady state continuous low to moderate intensity exercise with short bursts of high intensity exertion (eg in the form of sprints) is an effective, well tolerated, novel strategy to prevent exercise-related hypoglycemia. A further promising option to stabilize blood sugar levels during and after exercise may be the ingestion of fructose in addition to glucose in form of a sport drink.

Studieoversigt

Detaljeret beskrivelse

Background

Regular physical activity enhances insulin sensitivity in both healthy subjects and patients with diabetes mellitus. However, while the effects of physical activity on glucose control are undoubtedly beneficial in patients with type 2 diabetes, exercise can cause major disturbances in blood glucose levels in type 1 diabetic individuals. Hypoglycemia is a common complication in patients with T1DM engaging in endurance activities such as running and cycling. So far there are limited strategies suggested to improve exercise-related blood sugar self-management. Current recommendations focus on variation in timing and dosage of insulin administration and adjustments in carbohydrate intake. Since rapid adaptation of insulin dosage may be difficult, alternative strategies to improve exercise-related glucose stability are required. Increasing evidence suggests that intermittent high intensity exercise (IHE), by triggering a counterregulatory hormone response, may counter-balance the risk of exercise-associated hypoglycemia. However, previous studies investigating IHE in T1DM were limited by heterogeneous study populations, comparably short exercise protocols, and deficits in standardization procedures. In addition, a comprehensive assessment of the underlying fuel metabolism has not been performed so far. As a consequence, the results remain controversial and their interpretation as well as applicability are restricted.

A further alternative strategy to maintain stable glycemia during exercise may be deduced from recent studies in non-diabetic individuals suggesting that the combined ingestion of fructose and glucose during exercise provides the liver with an increased amount of gluconeogenic precursors, thereby reducing consumption of endogenous glycogen stores.Moreover, conversion of fructose into glucose and lactate may provide constant and efficient fuel for working muscles. However, studies assessing the impact of fructose ingestion during exercise in patients with T1DM have not been performed so far.

Objective

The investigators aim to assess the impact of two novel non-pharmaceutical and easily feasible approaches on exercise-related blood glucose stability and its underlying exercise-related fuel metabolism in patients with T1DM.

Substudy A will assess the influence on exercise-related glycemia and fuel metabolism of an IHE protocol compared to an iso-energetic continuous exercise (CONT). It will be investigated whether individuals reach more stable blood glucose levels when engaging in IHE compared to CONT.

Substudy B will investigate whether fueling the patients with a mixed oral 1:1 glucose-fructose carbohydrate solution will maintain glucose values within a more stable range when compared to carbohydrate supplementation by glucose alone.

Methods

Blood glucose levels, counterregulatory hormones, metabolites such as lactate and free fatty acids as well as inflammatory biomarkers will be assessed by regular blood samplings. By means of oral and intravenously given stable isotopes (U-13 C glucose and 2H glucose) exercise-related glucose kinetics will be investigated. Exercise-induced glycogen consumption will be measured using magnetic resonance spectroscopy technology. Late glycemic excursions will be recorded by continuous glucose monitoring systems.

In order to validate 13C magnetic resonance spectroscopy (MRS) measurement of hepatic and myocellular glycogen content a pre-study involving 10 patients and an equal number of matched healthy controls will be performed (validation and reproducibility study).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

27

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

      • Bern, Schweiz, 3010
        • Division of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital

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

18 år til 35 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  • Male
  • Aged 18 to 35 years
  • Diabetes mellitus duration for at least 5 years
  • No change in insulin regimen for at least 3 months prior to the study
  • Under acceptable to good metabolic control
  • Normal insulin sensitivity
  • Regular physical activity
  • BMI in the range of 18-25 kg/m2
  • Written informed consent

Exclusion Criteria

  • Diabetes-related complications (macro and microvascular)
  • Anemia (hemoglobin concentration <130g/l)
  • Abnormal thyroid function
  • Dyslipidemia
  • Major depression, psychosis and other severe personality disorders, claustrophobia
  • Active neoplasia
  • Contraindications to exposure to a 3 T magnetic field
  • Abnormal liver or renal function
  • Smoking, drug abuse, or daily alcohol consumption >60g
  • Participation in another study
  • Medication other than insulin

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: IHE first, CONT second, CSII and MDI therapy
IHE: intermittent high intensity exercise: integration of 10 s maximal sprints every 10 minutes in a continuous low to moderate intensity exercise of 90 minutes CONT (occurring after a washout period of 2-8 weeks): continuous moderate intensity exercise of 90 minutes
IHE: intermittent high intensity exercise: integration of 10 s maximal sprints every 10 minutes in a continuous low to moderate intensity exercise of 90 minutes. CONT (occurring after a washout period of 2-8 weeks): continuous moderate intensity exercise of 90 minutes
Eksperimentel: CONT first, IHE second,CSII and MDI therapy
CONT: continuous moderate intensity exercise of 90 minutes. IHE (occurring after a washout period of 2-8 weeks): intermittent high intensity exercise: integration of 10 s maximal sprints every 10 minutes in a continuous low to moderate intensity exercise of 90 minutes
CONT: continuous moderate intensity exercise of 90 minutes. IHE (occurring after a washout period of 2-8 weeks): intermittent high intensity exercise: integration of 10 s maximal sprints every 10 minutes in a continuous low to moderate intensity exercise of 90 minutes
Eksperimentel: GLU first, GLUFRU second, CSII and MDI therapy
GLU: ingestion of a 6% carbohydrate solution (consisting of 100 g glucose dissolved in 1000 ml tap water) over a continuous moderate exercise of 90 minutes. GLU FRU (occurring after a washout period of 2-8 weeks): ingestion of a 20% carbohydrate solution (consisting of 100 g glucose + 100 g fructose dissolved in 1000 ml tap water) over a continuous moderate exercise of 90 minutes. CSII = continuous subcutaneous insulin infusion. MDI=multiple daily injections.
: ingestion of a 6% carbohydrate solution (consisting of 90 g glucose dissolved in 1500 ml tap water) over a continuous moderate exercise of 90 minutes. GLU FRU (occurring after a washout period of 2-8 weeks): ingestion of a 12% carbohydrate solution (consisting of 90 g glucose + 90 g fructose dissolved in 1500 ml tap water) over a continuous moderate exercise of 90 minutes
Eksperimentel: GLU-FRU first, GLU second, CSII therapy
GLU-FRU : ingestion of a 20% carbohydrate solution (consisting of 100 g glucose + 100 g fructose dissolved in 1000 ml tap water) over a continuous moderate exercise of 90 minutes. GLU (occurring after a washout period of 2-8 weeks): ingestion of a 10% carbohydrate solution (consisting of 100 g glucose dissolved in 1000 ml tap water) over a continuous moderate exercise of 90 minutes. CSII = continuous subcutaneous insulin infusion. MDI=multiple daily injections.
GLU-FRU : ingestion of a 12% carbohydrate solution (consisting of 90 g glucose + 90 g fructose dissolved in 1500 ml tap water) over a continuous moderate exercise of 90 minutes. GLU (occurring after a washout period of 2-8 weeks): : ingestion of a 6% carbohydrate solution (consisting of 90 g glucose dissolved in 1500 ml tap water) over a continuous moderate exercise of 90 minutes.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Amount of exogenous glucose required to maintain glycemia within a range between 7-10mM
Tidsramme: 30 minutes (last 30 minutes of 90 min exercise period)
30 minutes (last 30 minutes of 90 min exercise period)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Exercise - related glycogen consumption
Tidsramme: 90 minutes
90 minutes
Glucose kinetics
Tidsramme: 180 minutes
Rate of glucose appearance and disappearance
180 minutes
Counterregulatory hormones, metabolites, and inflammatory response
Tidsramme: 300 minutes
300 minutes
Spiroergometric parameters
Tidsramme: 180 minutes
CO2 and O2 production, RER
180 minutes
Pre- and post-exercise glycemic excursions
Tidsramme: 72 h pre-exercise and 72 h post-exercise respectively
72 h pre-exercise and 72 h post-exercise respectively
Heart rate variability
Tidsramme: 90 minutes
90 minutes

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Christoph Stettler, Professor, MD, University of Bern

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. februar 2014

Primær færdiggørelse (Faktiske)

1. juli 2016

Studieafslutning (Faktiske)

1. juli 2016

Datoer for studieregistrering

Først indsendt

18. februar 2014

Først indsendt, der opfyldte QC-kriterier

19. februar 2014

Først opslået (Skøn)

21. februar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. august 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. august 2016

Sidst verificeret

1. august 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 001/14
  • 320030_149321/1 (Anden identifikator: Swiss National Science Foundation (SNF))
  • 191/10 (Anden identifikator: Ethics Committee (approval of measurements for healthy controls))

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 IHE first, CONT second

Abonner