The effect of exercise-induced hyperlacticacidemia on counterregulatory responses, symptoms, cognitive function and brain lactate accumulation during hypoglycemia in patients with type 1 diabetes with and without hypoglycemia unawareness and normal controls

Completed

Conditions: Diabetes
Type 1 Diabetes Mellitus
10018424

Registration Number: NL-OMON41023

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

age: 18-40 years
BMI: 18-30 kg/m2
blood pressure <160/90 mmHg
Recreationally active: i.e. taking part in competitive sport or regular exercise/physical activity, of a non-professional nature, once or more a week;For T1DM subjects:
Diabetes duration >1year
HbA1c: 42-75 mmol/mol (6-9%)
Outcome clarke questionnaire: 0-1 (normal awareness) or >=3 (hypoglycemia unawareness)

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
- For the MR study: MR(I) contraindications (pregnancy, severe claustrophobia, metal parts in body)
- Orthopedic and/or neurological diseases that impair exercise
- Cardiopulmonary disease ;For T1DM subjects:
- complications of T1DM, e.g. proliferative retinopathy, neuropathy or overt/clinical albuminuria
- Use of any other medication than insulin, except for oral contraceptives or stable thyroxine supplementation therapy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the plasma adrenaline response to hypoglycemia. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are levels of other plasma counterregulatory hormones,<br /><br>hypoglycemic symptom scores and cognitive functioning during hypoglycemia and<br /><br>the levels of inflammatory markers/cytokines. In addition we will measure brain<br /><br>lactate accumulation and brain perfusion after exercise in a subset of<br /><br>patients. </p><br>