Time Course and Nature of Nutrient Sensing During Fasting in Humans
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Nutrient Sensing During a Prolonged Fast |
Behavioral: Prolonged fasting |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Time Course and Nature of Nutrient Sensing During Fasting in Humans |
- Change in several proteins/ribonucleic acid (RNA) from muscle biopsies upon fasting [ Time Frame: 1.5h, 4h, 10h, 24h ] [ Designated as safety issue: No ]
- Change in several hormones, lipids etc. from blood samples upon fasting [ Time Frame: 1.5h, 4h, 10h, 24h ] [ Designated as safety issue: No ]
| Enrollment: | 12 |
| Study Start Date: | February 2011 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
healthy young and lean men
|
Behavioral: Prolonged fasting
48 hours of fasting
|
Eligibility| Ages Eligible for Study: | 19 Years to 29 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Netherlands | |
| Leiden University Medical Center | |
| Leiden, Zuid-Holland, Netherlands, 2333ZA | |
| Principal Investigator: | Hanno Pijl, MD, PhD | Leiden University Medical Center |
More Information
No publications provided
| Responsible Party: | Hanno Pijl, Leiden University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01387919 History of Changes |
| Other Study ID Numbers: | P10.164 |
| Study First Received: | July 1, 2011 |
| Last Updated: | July 8, 2011 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Leiden University Medical Center:
|
Set time points during 48 hours of fasting |
ClinicalTrials.gov processed this record on May 21, 2013