Time Course and Nature of Nutrient Sensing During Fasting in Humans (NCT01387919) | Clinical Trial Compass
CompletedNot Applicable
Time Course and Nature of Nutrient Sensing During Fasting in Humans
Netherlands12 participantsStarted 2011-02
Plain-language summary
Several studies have begun to determine the time course of events sensing energy availability in rodents. In contrast, there is not a single study that has examined this in humans to date. A better understanding of this energy sensing machinery in humans is of utmost importance to give us new insights into developing new therapies for common diseases such as obesity, diabetes mellitus, cardiovascular diseases and cancer. In these diseases, disturbances in the energy-sensing machinery possibly play a role. To determine the time course of energy sensing events in humans, the investigators will measure the concentration of various hormones in plasma, and biochemical changes in skeletal muscle at sequential time points during starvation in humans. The investigators choose to study the molecular machinery in muscle, since muscle is very sensitive to fuel deprivation.
Who can participate
Age range
19 Years – 29 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy males
* Age 19-29 years old
* Body mass index (BMI) 19-25 kg/m2
* Stable weight for the last 3 months
* Caucasian
* Fasting plasma glucose (FPG) \< 6 mmol/L
* Well-controlled blood pressure (\< 150/95 mmHg)
* Creatinine \<100 umol/l
* Hb \> 7.5 mmol/l
* Negative family history (first degree) of type 2 diabetes mellitus (DM2)
Exclusion Criteria:
* Use of medication known to affect glucose metabolism (for example prednisone) or lipid metabolism
* Significant (chronic) disease
* Smoking (current)
* Alcohol consumption of more than 14 units per week at present or in the past
* Difficult accessible veins for insertion of an intravenous catheter
* Recent blood donation (within the last 3 months)
* Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year
* Rigorous exercise/sports 5 or more days a week
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in several proteins/ribonucleic acid (RNA) from muscle biopsies upon fasting