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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03730909
Other study ID # Lactate_CBF
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 11, 2018
Est. completion date June 11, 2019

Study information

Verified date October 2018
Source Radboud University
Contact Bastiaan de Galan, PhD
Phone 0243613286
Email bastiaan.degalan@radboud.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It is thought that altered brain lactate handling is involved in the development of impaired awareness of hypoglycemia (IAH), i.e. the inability to timely detect hypoglycemia in people with type 1 diabetes (T1DM). Infusion of lactate diminishes symptomatic and hormonal responses to hypoglycemia in patients with normal awareness of hypoglycemia (NAH), resembling the situation of patients with IAH. It is unknown whether this attenuating effect is due to brain lactate oxidation or the result of lactate-induced alterations of global and regional cerebral blood flow (CBF).

Normally, hypoglycemia causes a redistribution of CBF towards the thalamus, from where the sympathetic response to hypoglycemia is coordinated, but in IAH this effect is absent and global CBF is increased. We hypothesize that lactate infusion in patients with NAH will result in blunting of thalamic activation and/or enhanced global CBF. If so, these results may help delineating the pathogenesis of IAH which eventually creates new avenues to protect against the morbidity associated with hypoglycemia and IAH.

Study design: Single-blind placebo controlled, randomized cross-over intervention study Study population: T1DM patients with NAH (n=10) Intervention: On two separate occasions, patients with T1DM and NAH will undergo a hyperinsulinemic euglycemic-hypoglycemic glucose clamp with or without the infusion of exogenous lactate. ASL-MRI will be applied to measure global and regional changes in CBF.

Main study parameters/endpoints: The change in regional thalamic CBF in response to intravenous lactate infusion compared to placebo, during hypoglycemia


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date June 11, 2019
Est. primary completion date April 11, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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

- Blood pressure: <160/90 mmHg

Exclusion Criteria:

- Inability to provide informed consent

- Use medication other than insulin, except for oral contraceptives or stable thyroxin 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 or cardiac failure, known liver disease, anxiety disorders or a history of panic attacks.

- Microvascular complications of T1DM: Proliferative retinopathy, symptomatic diabetic neuropathy (including autonomic neuropathy) or Nephropathy; clinical/overt albuminuria or an estimated glomerular filtration rate <60ml/min/1.73m2.

- MRI contraindications (pregnancy, severe claustrophobia, metal parts in body)

Study Design


Intervention

Drug:
Sodium Lactate
IV infusion
Sodium chloride
IV infusion

Locations

Country Name City State
Netherlands Radoud university medical center Nijmegen

Sponsors (1)

Lead Sponsor Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Regional CBF in ml/100g/min measured with ASL-MRI The change in regional thalamic CBF in response to intravenous lactate infusion compared to placebo, during hypoglycemia during stable euglycemia (40 minutes) and hypoglycemia (45 minutes)
Secondary Global CBF in ml/100g/min measured with ASL-MRI The change in global CBF in response to intravenous lactate infusion during stable euglycemia (40 minutes) and hypoglycemia (45 minutes)
Secondary Counterregulatory hormone responses to hypoglycemia The difference in adrenaline (pmol/L) responses to hypoglycemia during lactate infusion compared to placebo during stable euglycemia (40 minutes) and hypoglycemia (45 minutes)
Secondary Symptom responses to hypoglycemia The difference in symptom responses to hypoglycemia (meausured with a validated questionnaire) during lactate infusion compared to placebo during stable euglycemia (40 minutes) and hypoglycemia (45 minutes)
Secondary Measurements of metabolites in cell lysates or supernatants of the cultured immune cells The effect of lactate administration on immune cell function and metabolism during stable euglycemia (40 minutes) and hypoglycemia (45 minutes)
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