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

August 30, 2022 updated by: University of Aberdeen

Muscle Fat Compartments and Turnover as Determinant of Insulin Sensitivity - the MISTY Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Aberdeenshire
      • Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZN
        • Cardiac Research Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Detraining or training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-invasive 1H Magnetic Resonance Spectroscopy of vastus lateralis
Time Frame: One Hour
Assessment of energetics of vastus lateralis by MRS
One Hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Saturated and unsaturated lipid pool turnover examined by stable isotopes
Time Frame: One hour
Lipid pool turnover as examined by stable isotope infusion
One hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aberdeen

Collaborators

NHS Grampian

Investigators

  • Principal Investigator: Dana Dawson, MD, University of Aberdeen Employee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2016

Primary Completion (ACTUAL)

January 1, 2019

Study Completion (ACTUAL)

January 1, 2019

Study Registration Dates

First Submitted

December 7, 2016

First Submitted That Met QC Criteria

February 21, 2017

First Posted (ACTUAL)

February 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 31, 2022

Last Update Submitted That Met QC Criteria

August 30, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/NS/0024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

Clinical Trials on Training or detraining

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe