Exercise, Glucose Kinetics, and the Incretin Effect

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01607931
• Other study ID #: EFSD-2012
• Status: Completed
• Phase: N/A
• First received: May 23, 2012
• Last updated: August 11, 2016
• Start date: January 2013
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT01540097

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Exercise
1 hour of cycling at 50% of maximum power output

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose tolerance		Plasma glucose will be measured at 10 minute intervals during the OGTT (3 hours) immediately following the period of rest or exercise	No
Primary	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	No