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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00325559
• Other study ID #: 1122
• Status: Completed
• Phase: N/A
• First received: May 12, 2006
• Last updated: January 12, 2011
• Start date: June 2006

Study information

• Verified date: January 2011
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. primary completion date: March 2007
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Exercise
• Hyperglycemia

Intervention

Procedure:
• Normoinsulinemic eu- or hyperglycemic clamp

Locations

Country	Name	City	State
Switzerland	Department of Endocrinology, Diabetes and Clinical Nutrition, University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Paired difference in the time to complete a time trial corresponding to 5 km cycling between euglycaemia and hyperglycaemia
Secondary	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
Secondary	IMCL content during exercise in the working muscle
Secondary	Rate of appearance of glucose
Secondary	Rate of disappearance of glucose
Secondary	Rate of glucose infusion
Secondary	Total glucose oxidation
Secondary	Oxidation of endogenous glucose
Secondary	Oxidation of exogenous glucose
Secondary	Fat oxidation (calculated via tracer and via RER)
Secondary	Rate of perceived exertion
Secondary	Serum lactate levels during the exercise test
Secondary	Amino acid oxidation
Secondary	Serum free fatty acid concentration
Secondary	Serum insulin levels
Secondary	Serum glucose levels
Secondary	Time to achieve hyperglycemia during clamp
Secondary	Pretest diary data