Status:
COMPLETED
The Role of Endogenous Lactate in Brain Preservation and Counterregulatory Defenses Against Hypoglycemia
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Dutch Diabetes Research Foundation
European Foundation for the Study of Diabetes
Conditions:
Type 1 Diabetes Mellitus
Hypoglycemia Unawareness
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
Iatrogenic hypoglycemia is the most frequent acute complication of insulin therapy in people with type 1 diabetes (T1DM). Recurrent hypoglycemic events initiate a process of habituation, characterized...
Eligibility Criteria
Inclusion
- Inclusion criteria for healthy subjects
- Age: 18-40 years
- Body-Mass Index: 18-30 kg/m2
- Blood pressure: \<160/90 mmHg
- Recreationally active: i.e. taking part in competitive sport or regular exercise training, of a non-professional nature, once or more a week.
- Inclusion criteria T1DM patients with normal hypoglycemic awareness
- Diabetes duration ≥ 1 year
- Age: 18-40 years
- Body-Mass Index: 18-30 kg/m2
- HbA1c: 42-75 mmol/mol (6-9%)
- Outcome Clarke questionnaire: 0-1
- Blood pressure: \<160/90 mmHg
- Recreationally active: i.e. taking part in competitive sport or regular exercise training, of a non-professional nature, once or more a week
- Inclusion criteria T1DM patients with hypoglycemia unawareness
- Diabetes duration ≥ 1 year
- Age: 18-40 years
- Body-Mass Index: 18-30 kg/m2
- HbA1c: 42-75 mmol/mol (6-9%)
- Outcome Clarke questionnaire: =\>3
- Blood pressure: \<160/90 mmHg
- Recreationally active
- Exclusion criteria:
- Inability to provide informed consent
- Presence of any medical condition that might interfere with the study protocol, such as brain injuries, epilepsy, a major cardiovascular disease event or anxiety disorders
- Use of any medication, except for oral contraceptives
- MR(I) contraindications (pregnancy, severe claustrophobia, metal parts in body)
- Orthopedic and/or neurological diseases that impair exercise
- Cardiopulmonary disease as stated in the 2001 American heart association and 2002 American college of cardiology/American heart association guidelines
- Additional exclusion criteria for all T1DM patients:
- Use of any other medication than insulin, except for oral contraceptives or stable thyroxine supplementation therapy
- complications of T1DM, including proliferative retinopathy, neuropathy or nephropathy
Exclusion
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02308293
Start Date
January 1 2015
End Date
July 1 2016
Last Update
November 25 2016
Active Locations (1)
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1
Radboud umc
Nijmegen, Netherlands