NCT03065140

Brief Summary

Early research found that high levels of fat within muscle meant poorer control of blood sugar. However, more recent research has shown that athletes have similar levels of fat within muscle, but in contrast, they have very good control of blood sugar. The investigators are not sure why this is and want to find out if the fat within muscle can be changed to improve blood sugar control, as good blood sugar control reduces the risk of heart disease, diabetes and stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable 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

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

August 31, 2022

Status Verified

August 1, 2022

Enrollment Period

2.3 years

First QC Date

December 7, 2016

Last Update Submit

August 30, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Non-invasive 1H Magnetic Resonance Spectroscopy of vastus lateralis

    Assessment of energetics of vastus lateralis by MRS

    One Hour

Secondary Outcomes (1)

  • Saturated and unsaturated lipid pool turnover examined by stable isotopes

    One hour

Study Arms (2)

Healthy Volunteers

EXPERIMENTAL

Healthy volunteers will undergo the following: * CPEX with/without stable isotope infusion * Muscle biopsies * Magnetic Resonance Spectroscopy Followed by a period of detraining. They will then undergo the following: * CPEX with/without stable isotope infusion * Muscle biopsies * Magnetic Resonance Spectroscopy

Other: Training or detraining

Diabetic Patients

EXPERIMENTAL

Diabetic patients will undergo the following: * CPEX with/without stable isotope infusion * Muscle biopsies * Magnetic Resonance Spectroscopy They will then undergo a supervised training period. They will then undergo the following: * CPEX with/without stable isotope infusion * Muscle biopsies * Magnetic Resonance Spectroscopy

Other: Training or detraining

Interventions

A period of detraining or a supervised exercise program.

Also known as: Detraining or training
Diabetic PatientsHealthy Volunteers

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetic patients, aged between 20-65, diagnosed as per WHO criteria, diet controlled or diet and any of the following oral hypoglycemics: metformin, sulphonylureas, glitazones, gliptins, acarbose, but not requiring insulin for controlling of blood glucose.
  • Trained, athletic healthy controls, aged 18 and over.
  • Participant who is willing and able to give informed consent for participation in the study.
  • Able to perform exercise testing.

You may not qualify if:

  • Any history of known coronary artery disease.
  • Other endocrine conditions
  • Impaired renal function defined as eGFR\<60mls/min/1.73m2
  • Known resting/24 hour BP \>160/100mmHg
  • Participants on ACE inhibitors
  • Participants on PPAR agonists
  • Participants on omega 3 fatty acids
  • The existence of any medical or surgical condition that in the judgement of the investigators may interfere with the exercise regime, FA metabolism or may compromise the safety of the subject
  • Presence of other significant concomitant heart diseases such as ischaemic, valvular, pericardial heart disease or cardiomyopathy, skeletal muscle disorders
  • Healthy volunteers that are on any chronic medication that in the judgment of the investigators is likely to affect the outcome of the study
  • Significant asthma
  • Significant pulmonary disease
  • Participants unable to cycle on the ergometer
  • Unable to perform exercise testing (e.g. prosthetic limbs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiac Research Office

Aberdeen, Aberdeenshire, AB25 2ZN, United Kingdom

Location

Related Publications (35)

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  • ECG-Triggered and Respiratory Gated Image Based B0 Shimming for Single Voxel Spectroscopy of the Myocardium at 3T. 21st Annual Meeting and Exhibition of the International Society for Magnetic Resonance in Medicine (ISMRM 2013), Salt Lake City, UT, USA. 2013

    BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Dana Dawson, MD

    University of Aberdeen Employee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2016

First Posted

February 27, 2017

Study Start

September 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

August 31, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations