Use of a Hyperinsulinemic-hypyglycemic Clamp to Study Hypoglycemia: a Method Development Study
NCT ID: NCT03839511
Last Updated: 2021-08-19
Study Results
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View full resultsBasic Information
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COMPLETED
4 participants
OBSERVATIONAL
2018-11-28
2019-02-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Hyperinsulinemic-hypoglycemic clamp
Subjects will arrive at the inpatient unit in the morning after at least a 10 hour overnight fast. Upon arrival to PBRC, participants will be admitted to the inpatient unit. Following measurement of weight, vitals, and pregnancy test (women only), the 4-hour hypoglycemic clamp procedure (30 minute baseline, 120 minute insulin infusion, and 90 minute recovery) will be performed. Upon completion of the clamp procedure, participants will be provided lunch (Standard American Diet). Following lunch, the CGM sensor will be removed and pending a stable blood glucose level in the normal range, the participant will be discharged from the inpatient unit. This completes the study.
Eligibility Criteria
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Inclusion Criteria
* Ages 18-40 years
* BMI between 20 kg/m2 and 30 kg/m2 (±0.5 kg/m2 will be accepted)
* Medically cleared for participation in the study
Exclusion Criteria
* Average screening blood pressure \>140/90 mmHg
* History of cardiovascular disease
* Pregnant, planning to become pregnant, or breastfeeding
* Based on the investigative team's clinical judgement, a subject may not be appropriate for participation in the study.
18 Years
40 Years
ALL
No
Sponsors
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Pennington Biomedical Research Center
OTHER
Responsible Party
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David McDougal
Assistant Professor
Locations
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Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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2018-050-PBRC HYPOCLAMP
Identifier Type: -
Identifier Source: org_study_id
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