|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT03181217 |
|
Date of registration:
|
06/06/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Functional Magnetic Resonance Imaging of Human Hypothalamic Responses to Oral Temperature and Glucose Sensing
COLD |
|
Scientific title:
|
Functional Magnetic Resonance Imaging of Human Hypothalamic Responses to Oral Temperature and Glucose Sensing |
|
Date of first enrolment:
|
January 28, 2013 |
|
Target sample size:
|
16 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03181217 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Single (Outcomes Assessor).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
Jeroen van der Grond |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Leiden University Medical Center |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Signed informed consent
- Age between 18 and 25 years
- BMI between 20 and 23 kg/m2
- Length between 170 and 190 centimetres
Exclusion Criteria:
- Diabetes or history of other disturbances of glucose metabolism (eg impaired glucose
tolerance, hypoglycaemia).
- Any genetic or psychiatric disease (e.g. fragile X syndrome, major depression)
affecting brain
- Any significant chronic disease
- Renal or hepatic disease
- Recent weight changes or attempts to loose weight (> 3 kg weight gain or loss, within
the last 3 months)
- Smoking (current or last 6 months)
- Alcohol consumption of more than 21 units per week or use of recreational drugs at
present or in the last year
- Recent blood donation (within the last 2 months)
- Recent participation in other biomedical research projects (within the last 3 months),
participation in 2 or more biomedical research projects in one year
Age minimum:
18 Years
Age maximum:
25 Years
Gender:
Male
|
|
Health Condition(s) or Problem(s) studied
|
|
Healthy
|
|
Intervention(s)
|
|
Other: water 22
|
|
Other: Glucose 22
|
|
Other: Glucose 0
|
|
Other: water 0
|
|
Primary Outcome(s)
|
|
Functional magnetic resonance imaging of the hypothalamus
[Time Frame: fMRI measurements between 8 and 20 minutes after start of beverage intake]
|
|
Secondary Outcome(s)
|
|
Functional magnetic resonance imaging of the nucleus accumbens
[Time Frame: fMRI measurements between 8 and 20 minutes after start of beverage intake]
|
|
Functional magnetic resonance imaging of the amygdala
[Time Frame: fMRI measurements between 8 and 20 minutes after start of beverage intake]
|
|
Secondary ID(s)
|
|
FDS-BNH-0770
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|