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

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 - The effect of intravenous lactate on brain lactate during hypoglycemia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43132

Enrollment

Registered

2016-11-01

Start date

2016-11-25

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes Diabetes Mellitus

Interventions

Part 1: On two separate occasions, patients with T1DM and NAH will undergo hyperinsulinemic euglycemic-hypoglycemic glucose clamps with or without the infusion of exogenous lactate. 1H magnetic reso

awareness of hypoglycemia

lactate

T1DM

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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 >

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The main study parameter of part 1 is the change in brain lactate concentration in response to lactate infusion compared to placebo during hypoglycemia in patients with T1DM and NAH. The main endpoint of part 2 is the difference in brain lactate handling during hypoglycemia with lactate infusion between patients with T1DM and NAH compared to patients with IAH.	—

Secondary

Measure	Time frame
Secondary endpoints include the change in brain lactate upon infusion during euglycemia, changes in brain pH and differences between patients with T1DM-NAH and IAH.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)