The purpose of the study is to investigate ketogenesis and glucose dependant insulin secretion methodologies. In addition, blood samples will be collected to assess the feasibility of performing study procedures and sample processing.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
anti-obesity
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the logistics, feasibility, and safety of procedures for a clinical
trial that will assess methodologies used to evaluate ketogenesis and
glucose-dependent insulin secretion.
Secondary outcome
N/A
Background summary
Pilot Study to assess Ketogenesis and Glucose-Dependent Insulin Secretion
Methodologies in Healthy Male Subjects
Study objective
The purpose of the study is to investigate ketogenesis and glucose dependant
insulin secretion methodologies. In addition, blood samples will be collected
to assess the feasibility of performing study procedures and sample processing.
Study design
A randomized pilot study for ketogenesis and glucose-dependent insulin
secretion methodologies in two healthy male obese subjects.
Procedures and assessments:
Screening and follow-up:
Clinical laboratory, bloodpressure and vital signs, physical examination,
12-lead ECG, drug screen
Only by screening:
medical history, height, weight, HBsAG, anti HCV and anti-HIV.
Observation period:
-17 up to approx 9 hours after dosing
Study burden and risks
Procedures: pain, light bleeding, heamatoma and possibly an infection.
Stationsweg 163
9471 GP Zuidlaren
Nederland
Stationsweg 163
9471 GP Zuidlaren
Nederland
Listed location countries
Age
Inclusion criteria
18-45 years,
BMI 27-35 kg/m2 (inclusive)
Exclusion criteria
Suffering from: hepatitis B, cancer or HIV/Aids. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters blood in the 10 months preceding the start of the study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31792.056.10 |