The Effect of Hyperglycaemia on Local Energy Stores in the Working Muscle in Patients With Type 1 Diabetes Mellitus

Study Overview
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Brief Summary
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This study aims at investigating the effect of hyperglycaemia on physical performance and local energy stores in the muscle in patients with type 1 diabetes mellitus under exercise conditions.

Official Title
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The Effect of Hyperglycaemia on Local Energy Stores in the Working Muscle in Patients With Type 1 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 1, Exercise

Intervention / Treatment
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* Procedure: Normoinsulinemic eu- or hyperglycemic clamp


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male Aged from 20 to 40 years Patients with type 1 diabetes mellitus lasting for at least 5 years (C-Peptide ≤ 0.3 nmol/l in the presence of a plasma glucose level ≥ 7 mmol/L, indicating insulin dependence) Insulin delivery by CSII (continuous subcutaneous insulin infusion) for at least 6 months Acceptable to good metabolic control, reflected by an HbA1c 5-8% Normal insulin sensitivity, reflected by a daily insulin requirement of 0.3-1.0 U/kg body weight minimum 30' of moderate exercise 3 times per week BMI in the range of 18-25 kg/m2 Exclusion Criteria: Chronic complications of diabetes: Microalbuminuria (Mogensen nephropathy stadium ≥ III) Sensory neuropathy (vibration better than 5/8 at the metatarsophalangeal articulation of digitus I) Proliferating retinopathy No history of macro-vascular complications Clinically relevant autonomous neuropathy Smoking Abnormal thyroid function Major depression, psychosis and other severe personality disorders, claustrophobia Active neoplasia Contraindications to exposure to a 1.5 T magnetic field (pace-makers, osteosynthetic material, etc.) Abnormal liver or renal function (creatinine > 130 µmol/L; ASAT and ALAT > 3 times the upper reference limit) Excessive alcohol consumption (>60g/d) or drug-abuse Refusal to give written informed consent Participation in another study Patients, who are not suitable for the study according to the study physician

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Normoinsulinemic eu- or hyperglycemic clamp|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paired difference in the time to complete a time trial corresponding to 5 km cycling between euglycaemia and hyperglycaemia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle glycogen content during exercise in the working muscle (pre test vs. post test), in euglycaemia and hyperglycaemia respectively (All following endpoints are paired differences (euglycaemia vs. hyperglycaemia) of paired differences (pre |  |  | 
| IMCL content during exercise in the working muscle |  |  | 
| Rate of appearance of glucose |  |  | 
| Rate of disappearance of glucose |  |  | 
| Rate of glucose infusion |  |  | 
| Total glucose oxidation |  |  | 
| Oxidation of endogenous glucose |  |  | 
| Oxidation of exogenous glucose |  |  | 
| Fat oxidation (calculated via tracer and via RER) |  |  | 
| Rate of perceived exertion |  |  | 
| Serum lactate levels during the exercise test |  |  | 
| Amino acid oxidation |  |  | 
| Serum free fatty acid concentration |  |  | 
| Serum insulin levels |  |  | 
| Serum glucose levels |  |  | 
| Time to achieve hyperglycemia during clamp |  |  | 
| Pretest diary data |  |  |