Diabetes Mellitus, Type 1NCT00325559
The Effect of Hyperglycaemia on Local Energy Stores in the Working Muscle in Patients With Type 1 Diabetes Mellitus
A study testing Normoinsulinemic eu- or hyperglycemic clamp in people with Diabetes Mellitus, Type 1 and Exercise, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men only
- Conditions the study is for
- Diabetes Mellitus, Type 1, Exercise
- What is being tested?
- Normoinsulinemic eu- or hyperglycemic clamp
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2006to Mar 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Endocrinology, Diabetes and Clinical Nutrition, University Hospital
Bern, CH-3010
About this study
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.
- Conditions
- Diabetes Mellitus, Type 1, Exercise
- Being tested
- Normoinsulinemic eu- or hyperglycemic clamp
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normoinsulinemic eu- or hyperglycemic clampProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2006 (estimated)
- Study startJun 2006
- Primary completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Christoph Stettler, MD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325559
- Sponsor's protocol ID
- 1122
- Status last verified
- Jan 2011
- First submitted
- 12 May 2006
- Last updated
- 13 Jan 2011
- Results posted
- No
Publications
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.
PubMed 18512043
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hyperglycaemia on Local Energy Stores in the Working Muscle in Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00325559
- Acronym / sponsor ID
- 1122
- Conditions
- Diabetes Mellitus, Type 1, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Mar 2007 (actual)
- First posted
- 15 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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%
Key exclusion criteria (16 listed)
- Chronic complications of diabetes:
- Smoking
- Abnormal thyroid function
- Major depression, psychosis and other severe personality disorders, claustrophobia
- Active neoplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normoinsulinemic eu- or hyperglycemic clamp | Procedure or surgery | – |
Primary outcome
Paired difference in the time to complete a time trial corresponding to 5 km cycling between euglycaemia and hyperglycaemia
17 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2011.
- Derived from this study: PubMed 18512043Jenni 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Stettler, MD principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normoinsulinemic eu- or hyperglycemic clamp in people with Diabetes Mellitus, Type 1 and Exercise, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paired difference in the time to complete a time trial corresponding to 5 km cycling between euglycaemia and hyperglycaemia. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00325559, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2011.