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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 1 Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Interventions

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Normoinsulinemic eu- or hyperglycemic clamp

Intervention Type PROCEDURE

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No