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Maintaining health in old age through homeostasis- Phase II

Maintaining health in old age through homeostasis- Phase II - Switchbox

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-005650-29-NL
Enrollment
Unknown
Registered
2014-04-09
Start date
2014-04-25
Completion date
Unknown
Last updated
2014-05-12

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

Conditions

Glucose metabolism disorders (incl diabetes mellitus) MedDRA version: 16.1 Level: LLT Classification code 10058106 Term: Glucose metabolism abnormal System Organ Class: 100000004861

Interventions

Trade Name: Actrapid Pharmaceutical Form: Inhalation vapour, solution INN or Proposed INN: RECOMBINANT HUMAN INSULIN BIPHASIC ISOPHANE CAS Number: 12584-58-6 Current Sponsor code: P13.132 Other descri

Sponsors

Leiden University Medical Centre
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: young healthy volunteers from the general population Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Fasting plasma glucose > 7 mmol/L

Design outcomes

Primary

MeasureTime frame
Main Objective: To study the effects and sensitivity of INA insulin on brain function and neuro-endocrine and metabolic output in healthy volunteers. This will be done by examining: • Effect of INA insulin on pre- and post- OGTT resting state brain signals • Effect of INA insulin on hypothalamic BOLD signals before and after glucose load (fMRI) • Effect INA insulin on blood glucose and 2.5- hour hormone trajectories before and after glucose load (OGTT) ;Secondary Objective: Determine the effect(s) INA insulin before and after a 75g oral glucose load on metabolomic and transcriptomic parameters ;Primary end point(s): Determine the effect(s) INA insulin before and after a 75g oral glucose load on: 1. brain activation and response using resting state and functional magnetic resonance imaging (fMRI) 2. hypothalamic BOLD signals (mapping of activity in different brain areas) 3. blood glucose and hormone trajectories 4. metabolomic and transcriptomic parameters ;Timepoint(s) of evaluation of this end point: start date: 01-09-2013 End date: 01-09-2014—

Secondary

MeasureTime frame
Secondary end point(s): Determine the effect(s) INA insulin before and after a 75g oral glucose load on metabolomic and transcriptomic parameters ;Timepoint(s) of evaluation of this end point: start date: 01-09-2013 End date: 01-09-2014—

Countries

Netherlands

Contacts

Public ContactDiana van Heemst

LUMC

D.van_heemst@lumc.nl+31715266640

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026