Time Course and Nature of Nutrient Sensing During Fasting in Humans

This study has been completed.
Sponsor:
Collaborator:
Centre for Medical Systems Biology
Information provided by:
Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT01387919
First received: July 1, 2011
Last updated: July 8, 2011
Last verified: January 2011
  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

Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • Change in several proteins/ribonucleic acid (RNA) from muscle biopsies upon fasting [ Time Frame: 1.5h, 4h, 10h, 24h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387919

Locations
Netherlands
Leiden University Medical Center
Leiden, Zuid-Holland, Netherlands, 2333ZA
Sponsors and Collaborators
Leiden University Medical Center
Centre for Medical Systems Biology
Investigators
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 July 24, 2014