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High Intensity Interval Training and Skeletal Muscle Insulin Sensitivity

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
High-intenstiy interval training
Sponsored by
Maastricht University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University Maastricht

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIIT

Arm Description

This group of subjects will perform High Intensity Interval training 3x/week for 12 weeks

Outcomes

Primary Outcome Measures

Non-oxidative glucose disposal
Measured during a 2-step hyperinsulinemic-euglycemic clamp combined with indirect calorimetry

Secondary Outcome Measures

Skeletal muscle glycogen content
Assessed from skeletal muscle biopsies
Skeletal muscle insulin sensitivity
Measured during a 2-step hyperinsulinemic-euglycemic clamp
24 hour glycaemic profile
continuous glucose monitor
Skeletal muscle mitochondrial function assessed by Magnetic Resonance Spectroscopy Scan using 31P-MRS methodology, based on the phosphocreatine (PCr) recovery kinetics after exercise.
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).
Metabolic Flexibility during exercise assessed by indirect calorimetry.
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.
Ectopic Fat accumulation in the liver assessed by magnetic resonance spectroscopy.
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.
Maximal Acetylcarnitine formation in the upper-leg at rest and after exercise assessed by Magnetic Resonance Spectroscopy Scan
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.

Full Information

First Posted
November 14, 2017
Last Updated
September 13, 2022
Sponsor
Maastricht University
Collaborators
Netherlands Organisation for Scientific Research
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1. Study Identification

Unique Protocol Identification Number
NCT03405545
Brief Title
High Intensity Interval Training and Skeletal Muscle Insulin Sensitivity
Official Title
High Intensity Interval Training and Skeletal Muscle Insulin Sensitivity: Unraveling Health Effects and Underlying Mechanisms
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 28, 2018 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University
Collaborators
Netherlands Organisation for Scientific Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
1 group of participants that performs 12 weeks of HIIT with metabolic measurements before and after this training period
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIIT
Arm Type
Experimental
Arm Description
This group of subjects will perform High Intensity Interval training 3x/week for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
High-intenstiy interval training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Non-oxidative glucose disposal
Description
Measured during a 2-step hyperinsulinemic-euglycemic clamp combined with indirect calorimetry
Time Frame
9 hours
Secondary Outcome Measure Information:
Title
Skeletal muscle glycogen content
Description
Assessed from skeletal muscle biopsies
Time Frame
1 hour
Title
Skeletal muscle insulin sensitivity
Description
Measured during a 2-step hyperinsulinemic-euglycemic clamp
Time Frame
9 hours
Title
24 hour glycaemic profile
Description
continuous glucose monitor
Time Frame
48 hours
Title
Skeletal muscle mitochondrial function assessed by Magnetic Resonance Spectroscopy Scan using 31P-MRS methodology, based on the phosphocreatine (PCr) recovery kinetics after exercise.
Description
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).
Time Frame
1 hour
Title
Metabolic Flexibility during exercise assessed by indirect calorimetry.
Description
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.
Time Frame
30 minutes
Title
Ectopic Fat accumulation in the liver assessed by magnetic resonance spectroscopy.
Description
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.
Time Frame
1 hour
Title
Maximal Acetylcarnitine formation in the upper-leg at rest and after exercise assessed by Magnetic Resonance Spectroscopy Scan
Description
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.
Time Frame
1 hour
Other Pre-specified Outcome Measures:
Title
Effect of consumption of insulinogenic, CHO-rich drink post-exercise
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthijs Hesselink, Prof. PhD.
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vera Schrauwen-Hinderling, PhD
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Maastricht
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229ER
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

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High Intensity Interval Training and Skeletal Muscle Insulin Sensitivity

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