NCT04178603

Brief Summary

The study investigates the regulation of muscle glucose utilization during exercise and enhanced insulin sensitivity in recovery from exercise. This will be investigated in lean control subjects and obese insulin resistant subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

January 6, 2022

Status Verified

April 1, 2021

Enrollment Period

2.2 years

First QC Date

November 18, 2019

Last Update Submit

January 5, 2022

Conditions

Insulin ResistanceInsulin SensitivityType 2 Diabetes

Keywords

ExerciseInsulin ResistanceType 2 DiabetesGlucose UptakeInsulin Sensitivity

Outcome Measures

Primary Outcomes (1)

  • Muscle glucose uptake during exercise and enhanced insulin sensitivity in recovery from exercise.

    Muscle glucose uptake during exercise and during insulin stimulation in recovery from exercise (insulin sensitivity) will be determined based on the the Fick principle. Thus, arterio-venous difference (av difference) in blood glucose will be multiplied by arterial leg blood flow.

    Through study completion, an average of 1 year.

Secondary Outcomes (1)

  • Posttranslational modification of proteins in muscle biopsies.

    5 years

Other Outcomes (2)

  • Changes in content of metabolites in muscles and blood plasma as a result of exercise and during subsequent insulin stimulation.

    5 years

  • Changes in gene-expression in muscle as a result of exercise and during subsequent insulin stimulation.

    5 years

Study Arms (2)

Acute Exercise Trial

EXPERIMENTAL

Lean control subjects and insulin resistant subjects perform an acute bout of one-legged knee-extensor exercise. Glucose metabolism is investigated before exercise (basal), during exercise and for 120 min of recovery.

Other: Exercise, insulin infusion

Insulin Sensitivity post Exercise

EXPERIMENTAL

Lean control subjects and insulin resistant subjects perform an acute bout of one-legged knee-extensor exercise and insulin action is investigated 4 hours after cessation of exercise. Insulin action is investigated by a 120 min euglycemic-hyperinsulinemic euglycemic clamp.

Other: Exercise, insulin infusion

Interventions

Exercise, insulin infusionOTHER

Trial A: Acute one-legged exercise Trial B: Insulin infusion 4 hours after one-legged exercise

Acute Exercise TrialInsulin Sensitivity post Exercise

Eligibility Criteria

Age25 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy persons (no known disease) without diabetes in the family
  • No use of medications
  • Non-smokers
  • Men
  • Age 25-40 years
  • Physical activity level (VO2peak) between 30-50 mL O2/min/kg
  • Specific for the persons of normal weight:
  • BMI between 18.0 and 25.0
  • HOMA-IR ≤ 1.5
  • Glucose tolerant (intact response in relation to oral glucose tolerance test, OGTT)
  • Without metabolic syndrome (defined by the International Diabetes Federation in 2006)
  • Specific for the persons with overweight and insulin resistance:
  • BMI between 28.0 and 35.0
  • HOMA-IR ≥ 2.2
  • Glucose tolerant (intact response in relation to OGTT)

You may not qualify if:

  • Women
  • Elevated blood pressure (systolic above 140 mmHg, diastolic above 90 mmHg).
  • Persons who show signs of metabolic diseases, hematologic diseases, reduced liver function or other signs of disease that may affect the outcome of the study or the study subject's wellbeing will be excluded.
  • Disease during conclusion of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Exercise, Nutrition and Sports, Faculty of Sciences, University of Copenhagen

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Insulin ResistanceDiabetes Mellitus, Type 2Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System DiseasesBehavior

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
Model Details: Lean control subjects and obese insulin resistant subjects undergo two different trials (trial A and B). Trial A aims to investigate the effect of acute exercise and 2 hours recovery. Trial B aims to investigate insulin sensitivity for glucose uptake in recovery from exercise.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 18, 2019

First Posted

November 26, 2019

Study Start

July 5, 2018

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

January 6, 2022

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)