Recurrent Hypoglycemia in Type 1 Diabetes (Aim 2)

  • STATUS
    Recruiting
  • End date
    Dec 5, 2028
  • participants needed
    50
  • sponsor
    University of Minnesota
Updated on 5 October 2021
diabetes
hyperglycemia
hemoglobin a1c
glycosylated hemoglobin
hypoglycemia
hypoglycemic drugs

Summary

This study will explore the cerebral mechanisms of impaired awareness of hypoglycemia (IAH) in type 1 diabetics following exposure to experimental recurrent hypoglycemia (HG). To induce IAH, patients with T1D identified to have normal awareness of hypoglycemia (NAH) will undergo three 2-hour long hypoglycemic clamps. Neurochemical profiles will be measured by high field MRS before and after induction of IAH. Subject glycemic variability and activity/sleep for 1 week before each study will be monitored as all factors have been shown to alter responses to HG.

Description

The long-term goal of this project is to identify how recurrent hypoglycemia (HG) leads to the clinical syndrome of impaired awareness of hypoglycemia (IAH) in type 1 diabetes (T1D).

This study will test the hypothesis that recurrent HG in T1D leads to an upregulation in brain glucose transport and alterations in glutamatergic and GABAergic tone. The investigators will use MRS methodology that permits evaluation of cerebral cortex and hypothalamus in the same session to simultaneously evaluate the cerebral correlates/mediators of impaired awareness and impaired counterregulatory hormone responses (CRR). High MR data quality and reproducibility will be ensured by using high field MR scanners and technical advances (automated voxel placement, real-time voxel position, frequency, shim updates). Continuous glucose monitoring and actigraphy will be used to chronicle glucose variability and activity/exercise/sleep in the weeks before each experiment to assess the impact of these variables on IAH.

Details
Condition insulin-dependent diabetes, iddm, diabetes type 1, Insulin dependent diabetes mellitus, diabetes mellitus type 1, type 1 diabetes, type 1 diabetes mellitus, type i diabetes mellitus, Diabetes Mellitus, Type 1
Treatment Experimental hyperglycemia
Clinical Study IdentifierNCT04387422
SponsorUniversity of Minnesota
Last Modified on5 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Type 1 diabetes diagnosed on clinical or laboratory grounds
Diabetes duration 2 - 30 years
Hemoglobin A1C <8.5%

Exclusion Criteria

Impaired awareness of hypoglycemia as determined by the Cox and Gold questionnaires
Pregnant or plan to become pregnant during the study period
Uncontrolled hypertension (blood pressure > 145/95 mmHg at screening)
Evidence of autonomic neuropathy (presence of orthostatic hypotension or history of gastroparesis)
Proliferative retinopathy
Impaired kidney function (GFR < 45)
History of myocardial infarction, stroke, seizures, neurosurgical procedures, major depression requiring hospitalization within the last 5 years, arrhythmias
Current substance abuse
Use of drugs that can alter glucose metabolism including but not limited to glucocorticoids and niacin, and excluding insulin and glucose lowering drugs used to treat diabetes, as determined by a clinician
Inability to undergo MRI scanning, including but not limited to unable to remain still in an MRI scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs
Unable to complete all study visits or procedures, as determined by the investigator
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