Time Course and Nature of Nutrient Sensing During Fasting in Humans

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.

Study Overview

• Status: Completed
• Conditions: Nutrient Sensing During a Prolonged Fast
• Intervention / Treatment: Behavioral: Prolonged fasting

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Zuid-Holland
    • Leiden, Zuid-Holland, Netherlands, 2333ZA
      • Leiden University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 29 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; healthy young and lean men	Behavioral: Prolonged fasting; 48 hours of fasting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in several proteins/ribonucleic acid (RNA) from muscle biopsies upon fasting	1.5h, 4h, 10h, 24h

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in several hormones, lipids etc. from blood samples upon fasting	1.5h, 4h, 10h, 24h

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Collaborators: Centre for Medical Systems Biology
• Investigators: Principal Investigator: Hanno Pijl, MD, PhD, Leiden University Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: July 1, 2011
• First Submitted That Met QC Criteria: July 5, 2011
• First Posted (Estimate): July 6, 2011

Study Record Updates

• Last Update Posted (Estimate): July 11, 2011
• Last Update Submitted That Met QC Criteria: July 8, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: Set time points during 48 hours of fasting
• Other Study ID Numbers: P10.164