NCT01771614

Brief Summary

Experimental hyperglycemia (5 hours) will be induced via a constant- or fluctuating-rate glucose infusion to establish different patterns of glycemia in healthy individuals. The effects of these acute models of hyperglycemia on the adaptations to a single aerobic exercise bout will be tested. Changes in pancreatic endocrine function, insulin sensitivity, endothelial function, and oxidative stress will be measured.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

January 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
3.5 years until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

May 16, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

January 16, 2013

Last Update Submit

May 15, 2018

Conditions

Type 1 DiabetesType 2 Diabetes

Keywords

GlucotoxicityExerciseBeta-cell function

Outcome Measures

Primary Outcomes (1)

  • Pancreatic endocrine function

    The plasma insulin, C-peptide, and glucagon responses to a 0.33 g/kg intravenous glucose tolerance test (IVGTT) will be measured. In each trial, the IVGTT will be performed at T = 0, 6, 7, 9, and 24 hours.

    0, 6, 7, 9, and 24 hours

Secondary Outcomes (3)

  • Glucose tolerance

    0, 6, 7, 9, and 24 hours

  • Endothelial function

    0, 6, 7, 9, and 24 hours

  • Oxidative stress

    24 hours

Study Arms (3)

Normoglycemia + exercise

EXPERIMENTAL

At T = 0 h participants will undergo an intravenous glucose tolerance test (IVGTT, 0.33 g/kg glucose) immediately followed by a 4-hour rest period. At T = 5 h, participants will undertake 45 minutes of moderate-intensity (70% VO2max) bicycle ergometry. Immediately following (T = 6 h) and 1- (T = 7 h), 3- (T = 9 h), and 18- hours (T = 24 h) after exercise, participants will undergo additional IVGTTs.

Behavioral: Exercise

Steady-State Hyperglycemia + exercise

EXPERIMENTAL

At T = 0 h participants will undergo an intravenous glucose tolerance test (IVGTT, 0.33 g/kg glucose) immediately followed by a 4-hour rest period. During this time, steady-state hyperglycemia (\~10 mM) will be induced experimentally via a variable-rate intravenous infusion of 20% dextrose. At T = 5 h, participants will undertake 45 minutes of moderate-intensity (70% VO2max) bicycle ergometry. Immediately following (T = 6 h) and 1- (T = 7 h), 3- (T = 9 h), and 18- hours (T = 24 h) after exercise, participants will undergo additional IVGTTs.

Behavioral: ExerciseProcedure: Hyperglycemia

Fluctuating Hyperglycemia + exercise

EXPERIMENTAL

At T = 0 h participants will undergo an intravenous glucose tolerance test (IVGTT, 0.33 g/kg glucose) immediately followed by a 4-hour rest period. During this time, fluctuating hyperglycemia (\~8-15 mM) will be induced by intravenously injecting 0.15 g/kg boluses of 20% dextrose every 30 minutes. At T = 5 h, participants will undertake 45 minutes of moderate-intensity (70% VO2max) bicycle ergometry. Immediately following (T = 6 h) and 1- (T = 7 h), 3- (T = 9 h), and 18- hours (T = 24 h) after exercise, participants will undergo additional IVGTTs.

Behavioral: ExerciseProcedure: Hyperglycemia

Interventions

ExerciseBEHAVIORAL
Fluctuating Hyperglycemia + exerciseNormoglycemia + exerciseSteady-State Hyperglycemia + exercise
HyperglycemiaPROCEDURE
Fluctuating Hyperglycemia + exerciseSteady-State Hyperglycemia + exercise

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Age 18-50 years
  • Body Mass Index 19-30 kg/m2
  • Generally healthy

You may not qualify if:

  • Regular use of anti-inflammatory medication
  • Smokers
  • More than 2 kg weight change in prior 6 months
  • Previous weight loss surgery
  • Cancer, or evidence of chronic haematological, pulmonary, cardiac, hepatic, renal, or gastrointestinal disease
  • Evidence of diabetes
  • Engaged in moderate or vigorous activity on more than 5 days per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Birmingham

Birmingham, West Midlands, B15 2TT, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Thomas P Solomon, PhD

    University of Birmingham

    PRINCIPAL INVESTIGATOR
0

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
Associate Professor

Study Record Dates

First Submitted

January 16, 2013

First Posted

January 18, 2013

Study Start

August 1, 2016

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

May 16, 2018

Record last verified: 2018-05

Locations

GB(1)