Exercise, Glucose Kinetics, and the Incretin Effect

NCT ID: NCT01607931

Last Updated: 2016-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-07-31

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Resting Trial

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Exercise Trial

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

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

1 hour of cycling at 50% of maximum power output

Interventions

Exercise

1 hour of cycling at 50% of maximum power output

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Thomas Solomon

Senior Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

EFSD-2012

Identifier Type: -

Identifier Source: org_study_id

NCT01540097

Identifier Type: -

Identifier Source: nct_alias