The effect of intravenous lactate administration on brain lactate concentrations and pH during euglycemia and hypoglycemia in patients with type 1 diabetes with and without impaired awareness of hypoglycemia

Completed

Conditions: diabetes
Diabetes Mellitus
10018424

Registration Number: NL-OMON43132

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- Diabetes duration * 1 year
- Age: 18-50 years
- Body-Mass Index: 18-30 kg/m2
- HbA1c: 42-75 mmol/mol (6-9%)
- Outcome Clarke questionnaire: 0-1 or ><=3
- Blood pressure: <160/90 mmHg

Exclusion Criteria

- Inability to provide informed consent
- Use of medication other than insulin, oral contraceptives or stable thyroxine supplementation therapy
- Presence of any other medical condition that might interfere with the study protocol, such as brain injuries, epilepsy, a major cardiovascular disease event, known liver disease, anxiety disorders or a history of panic attacks.
- Microvascular complications of T1DM except background retinopathy
- MR(I) contraindications, such as pregnancy, severe claustrophobia, metal parts in body

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter of part 1 is the change in brain lactate concentration<br /><br>in response to lactate infusion compared to placebo during hypoglycemia in<br /><br>patients with T1DM and NAH. The main endpoint of part 2 is the difference in<br /><br>brain lactate handling during hypoglycemia with lactate infusion between<br /><br>patients with T1DM and NAH compared to patients with IAH. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include the change in brain lactate upon infusion during<br /><br>euglycemia, changes in brain pH and differences between patients with T1DM-NAH<br /><br>and IAH. </p><br>