Time Course and Nature of Nutrient Sensing During Fasting in Humans

NCT01387919 | Completed

• 1 other identifier: P10.164
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nutrient Sensing During a Prolonged Fast

Keywords

Set time points during 48 hours of fasting

Outcome Measures

Primary Outcomes (1)

• Change in several proteins/ribonucleic acid (RNA) from muscle biopsies upon fasting

  1.5h, 4h, 10h, 24h

Secondary Outcomes (1)

• Change in several hormones, lipids etc. from blood samples upon fasting

  1.5h, 4h, 10h, 24h

Study Arms (1)

1

EXPERIMENTAL

healthy young and lean men

Behavioral: Prolonged fasting

Interventions

Prolonged fasting BEHAVIORAL

48 hours of fasting

1

Eligibility Criteria

• Age: 19 Years - 29 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Centre for Medical Systems Biology: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

Location

Study Officials

• Hanno Pijl, MD, PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: July 6, 2011
• Study Start: February 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: July 11, 2011

Record last verified: 2011-01

Locations

NL (1)