High Intensity Interval Training and Skeletal Muscle Insulin Sensitivity

September 13, 2022 updated by: Maastricht University

High Intensity Interval Training and Skeletal Muscle Insulin Sensitivity: Unraveling Health Effects and Underlying Mechanisms

This human intervention study will test if 12 weeks of supervised HIIT-based intervention improves skeletal muscle NOGD capacity in obese subjects.

Study Overview

Status

Completed

Detailed Description

19 overweight-obese (BMI => 27kg/m2), sedentary females and males aged 45-75yr will be enrolled in this study.

Participants will train 3 times/week under supervision during 12 weeks. Before, after and during this 12-week training period, there will be multiple metabolic measurements.

Study Type

Interventional

Enrollment (Actual)

19

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

    • Limburg
      • Maastricht, Limburg, Netherlands, 6229ER
        • University Maastricht

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

45 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent
  • Age 45 - 75 years old
  • Overweight to obese (BMI => 27kg/m2)
  • Sedentary - subjects do not perform any regular physical activity weekly(<3 times per week, <150 min/week).

Exclusion Criteria:

  • Unstable body weight (weight gain or loss > 3 kg in the past three months)
  • Participation in an intensive weight-loss program or in vigorous exercise program during the last year before starting the study.
  • HbA1c > 6.5% and glucose clearance rate >350 ml/kg/min (by OGTT).
  • Previously diagnosed with type 2 diabetes
  • Active cardiovascular disease. This will be determined by the questionnaires and by screening on medication.
  • Use of beta-blockers
  • Anticoagulant therapy
  • Systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg
  • Abuse of alcohol (> 3 units (1 unit = 10 gr ethanol) per day)
  • Any contra-indication to Magnetic Resonance Imaging (MRI) scanning
  • Participation in another biomedical study within 1 month before the first study visit, which may interfere with the outcomes of the present study.
  • Use of any medication affecting the glucose homeostasis and whole body metabolism or diseases that may significantly interfere with the main aim of the study.
  • Chronic renal dysfunction (creatinine >2 increased (normal value 64-104 µmol/l)
  • Subjects who do not want to be informed about unexpected medical findings during the screening / study, or do not wish that their physician is informed, cannot participate in the study.
  • Subjects will be included only when the dependent medical doctor of this study approves participation after evaluating all data obtained during the screening.

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: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HIIT
This group of subjects will perform High Intensity Interval training 3x/week for 12 weeks
High-intensity interval training is a training of 30 minutes involving 10 bouts of 1 minute high intensity cycling (80-90% of maximum heart rate) interspersed by 2 minutes rest.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-oxidative glucose disposal
Time Frame: 9 hours
Measured during a 2-step hyperinsulinemic-euglycemic clamp combined with indirect calorimetry
9 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skeletal muscle glycogen content
Time Frame: 1 hour
Assessed from skeletal muscle biopsies
1 hour
Skeletal muscle insulin sensitivity
Time Frame: 9 hours
Measured during a 2-step hyperinsulinemic-euglycemic clamp
9 hours
24 hour glycaemic profile
Time Frame: 48 hours
continuous glucose monitor
48 hours
Skeletal muscle mitochondrial function assessed by Magnetic Resonance Spectroscopy Scan using 31P-MRS methodology, based on the phosphocreatine (PCr) recovery kinetics after exercise.
Time Frame: 1 hour
The participant is positioned in the scanner with a home-built exercise device to perform consecutive knee-extensions, in which the participant has to lift a weight whilst laying in the scanner (50-60% max leg capacity of the subjects) for 5 minutes. Scout images of the upper leg are acquired and fine-tuned shimming is applied. Before, during and after exercise, spectra are acquired every 4 seconds. The restoration of PCr is driven almost purely by oxidative metabolism, the time to restore the normal amount reflects mitochondrial function (a faster restoration time means better mitochondrial function).
1 hour
Metabolic Flexibility during exercise assessed by indirect calorimetry.
Time Frame: 30 minutes
Participants will undergo a standardized cycling test at low, moderate and high intensity (30%-50%-70%) during 10 minutes each. Throughout the test, indirect calorimetry will be performed in order to measure changes in substrate oxidation during exercise.
30 minutes
Ectopic Fat accumulation in the liver assessed by magnetic resonance spectroscopy.
Time Frame: 1 hour
Participants will undergo a magnetic resonance spectroscopy scan from which hepatic fat content will be quantified. In the 1H-MRS spectra, the water signal, that is dominating the proton spectra, will be suppressed using frequency-selective pre-pulse and the spectra will be fitted to quantify the lipid peak. A separate spectrum will be measured without water suppression to quantify the unsuppressed water signal. The CH2/Water ratio will be used as parameter of intrahepatic lipid content.
1 hour
Maximal Acetylcarnitine formation in the upper-leg at rest and after exercise assessed by Magnetic Resonance Spectroscopy Scan
Time Frame: 1 hour
Magnetic resonance imaging (MRI) will be used to guide the spectroscopy measurements and fine shimming will be performed to optimize the magnetic field homogeneity within the region of interest. A volume of interest will be selected within the m. vastus lateralis from the MRI images and the 1H-MRS spectra will be acquired from this region of interest. The intensity of the creatine signal will be used as internal reference.
1 hour

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of consumption of insulinogenic, CHO-rich drink post-exercise
Time Frame: 12 weeks
Investigate whether the consumption of a insulinogenic, CHO-rich drink post-training prevention adverse effects related to blood glucose fluctuation while maintaining the effects of 12 weeks of HIIT on NOGD.
12 weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Vera Schrauwen-Hinderling, PhD, Maastricht University
  • Principal Investigator: Matthijs Hesselink, Prof. PhD., Maastricht University

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)

March 28, 2018

Primary Completion (ACTUAL)

October 1, 2021

Study Completion (ACTUAL)

October 1, 2021

Study Registration Dates

First Submitted

November 14, 2017

First Submitted That Met QC Criteria

January 12, 2018

First Posted (ACTUAL)

January 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • NL62654.068.17

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.

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