NCT01812590

Brief Summary

Subjects with type 2 diabetes will be stratified into two-quantiles based on ambient hyperglycemia (fasting glucose and HbA1c) and then the effects of a single aerobic exercise bout (1-hour at 50%VO2max) on pancreatic endocrine function will be determined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2013

Shorter than P25 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

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

January 31, 2014

Status Verified

January 1, 2014

Enrollment Period

5 months

First QC Date

March 14, 2013

Last Update Submit

January 30, 2014

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Pancreatic endocrine function

    Insulin and glucagon secretory responses to intravenous glucose (hyperglycemic clamp 5.4 mmol/l above basal), glucagon-like peptide-1 (0.5 pmol/kg/min), and arginine (5 g injection) will be determined.

    24-hours following a period of rest/exercise

Study Arms (2)

Resting Trial

NO INTERVENTION

Pancreatic endocrine function will be determined the morning following a day where no exercise is performed

Exercise Trial

EXPERIMENTAL

Pancreatic endocrine function will be determined the morning following a day where a 1-hour aerobic exercise is performed at 65% of pre-determined HRmax (maximal heart rate measured during an incremental work-load exercise test to volitional exhaustion)

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL
Exercise Trial

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previous diagnosis with type 2 diabetes, or newly detected in our screening procedures
  • Age 30-70 years
  • BMI 20-40 kg/m2

You may not qualify if:

  • Treatment with insulin
  • Contraindication to exercise as determined by ECG
  • Pregnancy
  • Active weight loss in the previous 6 months
  • Actively engaged in exercise training programs
  • Evidence of chronic pulmonary, cardiovascular, hepatic, renal, or hematological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

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

Study Record Dates

First Submitted

March 14, 2013

First Posted

March 18, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2013

Study Completion

October 1, 2013

Last Updated

January 31, 2014

Record last verified: 2014-01

Locations

DK(1)