Type 1 Diabetes Mellitus Clinical Trial
Official title:
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.
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).
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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