NCT01299831

Brief Summary

The purpose of this study is to investigate signaling pathways in fat and muscle, as well as turnover of protein, sugar and fat after stimulation with growth hormone and during fasting in lean and obese subjects. This will help clarify differences in the human metabolism between lean and obese subject and provide us with a better understanding of the molecular mechanisms regulating the basic metabolism during prolonged fasting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2011

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 26, 2014

Status Verified

May 1, 2014

Enrollment Period

2.9 years

First QC Date

January 21, 2011

Last Update Submit

May 23, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Measurements of changes in metabolism

    Measurements of the switch to lipid metabolism during fasting in lean and obese human subjects.

    6 hours

Secondary Outcomes (1)

  • Signaling pathways in muscle and fat tissue involved in regulation of metabolism

    6 hours

Study Arms (4)

72 hour fast

EXPERIMENTAL
Behavioral: 72 hour fast

12 hours fast

EXPERIMENTAL
Behavioral: control, 12 hour fast

12 hour fast, growth hormone bolus

EXPERIMENTAL
Drug: Growth hormone

72 hour fast, inhibition of lipolysis

EXPERIMENTAL
Drug: Olbetam

Interventions

72 hour fastBEHAVIORAL

The participants will be fasting 72 hours prior to the start of the study day, drinking water is allowed.

72 hour fast
control, 12 hour fastBEHAVIORAL

The 12 hour fast will be used as a basic metabolic control

12 hours fast
Growth hormoneDRUG

Genotropin bolus(0,005 mg/kg over 20 min.) will be administered at the beginning of the study day after a 12 hour fast.

12 hour fast, growth hormone bolus
OlbetamDRUG

The participants will be fasting 72 hours prior to the start of the study day, drinking water is allowed. During the last 12 hours of fasting and the study day lipolysis will be inhibited with one tablet of olbetam 250 mg every 4 hours.

72 hour fast, inhibition of lipolysis

Eligibility Criteria

Age20 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy lean (BMI19-25) and healthy obese (BMI 32-40) men
  • written consent before study start

You may not qualify if:

  • known medical conditions
  • any medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of medical endocrinology, University Hospital of Aarhus

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • Hogild ML, Bak AM, Pedersen SB, Rungby J, Frystyk J, Moller N, Jessen N, Jorgensen JOL. Growth hormone signaling and action in obese versus lean human subjects. Am J Physiol Endocrinol Metab. 2019 Feb 1;316(2):E333-E344. doi: 10.1152/ajpendo.00431.2018. Epub 2018 Dec 21.

    PMID: 30576246DERIVED

MeSH Terms

Interventions

Growth Hormoneacipimox

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2011

First Posted

February 18, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 26, 2014

Record last verified: 2014-05

Locations

DK(1)