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Exercise, Glucose Kinetics, and the Incretin Effect

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Exercise
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes focused on measuring Exercise, Physical activity, Type 2 diabetes, Obesity, Incretin effect, GLP-1, GIP, Insulin secretion, Glucagon, Beta-cell function, Disposition Index

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Resting Trial

Exercise Trial

Arm Description

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

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

Outcomes

Primary Outcome Measures

Glucose tolerance
Incretin effect

Secondary Outcome Measures

Full Information

First Posted
May 23, 2012
Last Updated
August 11, 2016
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01607931
Brief Title
Exercise, Glucose Kinetics, and the Incretin Effect
Official Title
The Effects of Acute Exercise on Glucose Kinetics, Beta-cell Function and the Incretin Effect in Subjects Representative of the Whole Glucose Tolerance Continuum
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Exercise, Physical activity, Type 2 diabetes, Obesity, Incretin effect, GLP-1, GIP, Insulin secretion, Glucagon, Beta-cell function, Disposition Index

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resting Trial
Arm Type
No Intervention
Arm Description
a 1 hour period of rest immediately prior to OGTT or isoglycemic clamp
Arm Title
Exercise Trial
Arm Type
Experimental
Arm Description
a 1 hour cycling exercise bout immediately prior to the OGTT or isoglycemic clamp
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
1 hour of cycling at 50% of maximum power output
Primary Outcome Measure Information:
Title
Glucose tolerance
Time Frame
Plasma glucose will be measured at 10 minute intervals during the OGTT (3 hours) immediately following the period of rest or exercise
Title
Incretin effect
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age 18-60 years BMI 18-35 kg/m2 Exclusion Criteria: 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
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

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Exercise, Glucose Kinetics, and the Incretin Effect

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