Time Course and Nature of Nutrient Sensing During Fasting in Humans

NCT ID: NCT01387919

Last Updated: 2011-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Nutrient Sensing During a Prolonged Fast

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

healthy young and lean men

Group Type EXPERIMENTAL

Prolonged fasting

Intervention Type BEHAVIORAL

48 hours of fasting

Interventions

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Prolonged fasting

48 hours of fasting

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

29 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre for Medical Systems Biology

UNKNOWN

Sponsor Role collaborator

Leiden University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Leiden University Medical Center

Principal Investigators

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Hanno Pijl, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

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Leiden University Medical Center

Leiden, South Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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P10.164

Identifier Type: -

Identifier Source: org_study_id

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