NCT00325559

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2006

Completed
17 days until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Last Updated

January 13, 2011

Status Verified

January 1, 2011

Enrollment Period

9 months

First QC Date

May 12, 2006

Last Update Submit

January 12, 2011

Conditions

Diabetes Mellitus, Type 1Exercise

Outcome Measures

Primary Outcomes (1)

  • Paired difference in the time to complete a time trial corresponding to 5 km cycling between euglycaemia and hyperglycaemia

Secondary Outcomes (17)

  • 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

  • +12 more secondary outcomes

Interventions

Normoinsulinemic eu- or hyperglycemic clampPROCEDURE

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Diabetes and Clinical Nutrition, University Hospital

Bern, CH-3010, Switzerland

Location

Related Publications (1)

  • Jenni S, Oetliker C, Allemann S, Ith M, Tappy L, Wuerth S, Egger A, Boesch C, Schneiter P, Diem P, Christ E, Stettler C. Fuel metabolism during exercise in euglycaemia and hyperglycaemia in patients with type 1 diabetes mellitus--a prospective single-blinded randomised crossover trial. Diabetologia. 2008 Aug;51(8):1457-65. doi: 10.1007/s00125-008-1045-5. Epub 2008 May 30.

    PMID: 18512043DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Officials

  • Christoph Stettler, MD

    University hospital of Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2006

First Posted

May 15, 2006

Study Start

June 1, 2006

Primary Completion

March 1, 2007

Last Updated

January 13, 2011

Record last verified: 2011-01

Locations

CH(1)