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Muscle Fat Compartments and Turnover as Determinant of Insulin Sensitivity (MISTY)

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ClinicalTrials.gov Identifier: NCT03065140
Recruitment Status : Unknown
Verified May 2018 by University of Aberdeen.
Recruitment status was:  Recruiting
First Posted : February 27, 2017
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
NHS Grampian
Information provided by (Responsible Party):
University of Aberdeen

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.

Condition or disease Intervention/treatment Phase
Diabetes Other: Training or detraining Not Applicable

Detailed Description:
Higher levels of triglycerides (TG) and diacylglycerols (DAG) are found in skeletal muscle of patients with obesity/diabetes as well as in trained athletes. Despite similar metabolic storage, patients and athletes have opposite insulin sensitivity phenotypes and an explanation for this is lacking. The investigators' objective is to understand how these fat compartments can be beneficially modulated to improve insulin resistance and cardio-metabolic risk. The investigators will investigate if either structural differences (saturated versus unsaturated balance of TG and DAG side-chains) or different handling abilities (fast versus slow lipid pool turnover) will be induced by exercise capacity interventions in athletes and in diabetic patients. In a longitudinal study pre- and post-exercise, the investigators will use novel, non-invasive 1H-Magnetic Resonance Spectroscopy to benchmark the saturated/unsaturated compartments against skeletal muscle biopsies for the first time and stable isotope analysis for fat compartments' rate of turnover.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Muscle Fat Compartments and Turnover as Determinant of Insulin Sensitivity - the MISTY Study
Study Start Date : September 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Arm Intervention/treatment
Experimental: Healthy Volunteers

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
A period of detraining or a supervised exercise program.
Other Name: Detraining or training

Experimental: Diabetic Patients

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
A period of detraining or a supervised exercise program.
Other Name: Detraining or training




Primary Outcome Measures :
  1. Non-invasive 1H Magnetic Resonance Spectroscopy of vastus lateralis [ Time Frame: One Hour ]
    Assessment of energetics of vastus lateralis by MRS


Secondary Outcome Measures :
  1. Saturated and unsaturated lipid pool turnover examined by stable isotopes [ Time Frame: One hour ]
    Lipid pool turnover as examined by stable isotope infusion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03065140


Contacts
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Contact: Dana Dawson, MD 01224437969 dana.dawson@abdn.ac.uk
Contact: Alice Mezincescu, MD 01224559573 alice.mezincescu@abdn.ac.uk

Locations
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United Kingdom
Cardiac Research Office Recruiting
Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZN
Contact: Alice Mezincescu, MD    01224559573    alice.mezincescu@abdn.ac.uk   
Contact: Amelia Rudd, HND    01224559573    a.e.rudd@abdn.ac.uk   
Sponsors and Collaborators
University of Aberdeen
NHS Grampian
Investigators
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Principal Investigator: Dana Dawson, MD University of Aberdeen Employee
Publications:
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

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Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT03065140    
Other Study ID Numbers: 16/NS/0024
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases