NCT01607931

Brief Summary

Human volunteers will be stratified by oral glucose tolerance status: normal glucose tolerant, impaired glucose tolerant, and type 2 diabetic. All subjects will undergo 4 experimental trials: \[1\] an oral glucose tolerance test (OGTT) combined with infused and ingested stable isotopes of glucose to assess glucose kinetics. \[2\] a 1 hour bout of cycling exercise at 50% of maximum power output, immediately followed by the same OGTT combined with stable isotope glucose tracers used in trial 1. \[3\] an isoglycemic clamp to match the plasma glucose profile measured in trial 1. \[4\] a 1 hour bout of cycling exercise at 50% of maximum power output, immediately followed by an isoglycemic clamp to match the plasma glucose profile measured in trial 2. Exercise-induced changes in oral glucose tolerance, glucose kinetics, insulin and glucagon secretion, and the incretin effect will be examined. The exercise responses will be compared between the subjects groups of different glucose tolerance status.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable type-2-diabetes

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

First Submitted

Initial submission to the registry

May 23, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 30, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 12, 2016

Status Verified

August 1, 2016

Enrollment Period

3.2 years

First QC Date

May 23, 2012

Last Update Submit

August 11, 2016

Conditions

Keywords

ExercisePhysical activityType 2 diabetesObesityIncretin effectGLP-1GIPInsulin secretionGlucagonBeta-cell functionDisposition Index

Outcome Measures

Primary Outcomes (2)

  • Glucose tolerance

    Plasma glucose will be measured at 10 minute intervals during the OGTT (3 hours) immediately following the period of rest or exercise

  • Incretin effect

    Plasma insulin and C-peptide will be measured at 10 minute intervals during the OGTT (3 hours) and isoglycemic clamp (3 hours) immediately following the period of rest or exercise

Study Arms (2)

Resting Trial

NO INTERVENTION

a 1 hour period of rest immediately prior to OGTT or isoglycemic clamp

Exercise Trial

EXPERIMENTAL

a 1 hour cycling exercise bout immediately prior to the OGTT or isoglycemic clamp

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

1 hour of cycling at 50% of maximum power output

Exercise Trial

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-60 years
  • BMI 18-35 kg/m2

You may not qualify if:

  • insulin dependency
  • pregnancy
  • presence or history of chronic cardiovascular, pulmonary, hepatic, renal, or hematological disease, or cancer
  • contraindication to physical activity as assessed by ECG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor ActivityObesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehaviorOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

May 23, 2012

First Posted

May 30, 2012

Study Start

January 1, 2013

Primary Completion

April 1, 2016

Study Completion

July 1, 2016

Last Updated

August 12, 2016

Record last verified: 2016-08

Locations