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NCT Number: NCT01387919

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.

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Key information

Conditions

Nutrient Sensing During a Prolonged Fast

Age range

19 year–29 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prolonged fasting

Behavioral

48 hours of fasting

Primary outcomes

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

    Time frame: 1.5h, 4h, 10h, 24h

Secondary outcomes

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

    Time frame: 1.5h, 4h, 10h, 24h

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Centre for Medical Systems Biology

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 6, 2011
Registry last updated
Jul 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.