CClinicalTrials.gg
CompletedNCT03405545Updated Sep 14, 2022

High Intensity Interval Training and Skeletal Muscle Insulin Sensitivity

An interventional study of High-intenstiy interval training in Overweight and Obesity, sponsored by Maastricht University. Completed at 1 site in Netherlands. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-14.

Sponsored by Maastricht University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
45 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Overweight and Obesity
03

Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    HIIT

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

    Behavioral: High-intenstiy interval training

Interventions

  • BehavioralHigh-intenstiy interval training

    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.

05

What researchers measure

Primary outcomes

  1. Non-oxidative glucose disposal

    Measured during a 2-step hyperinsulinemic-euglycemic clamp combined with indirect calorimetry

    Time frame: 9 hours

Secondary outcomes

  1. Skeletal muscle glycogen content

    Assessed from skeletal muscle biopsies

    Time frame: 1 hour

  2. Skeletal muscle insulin sensitivity

    Measured during a 2-step hyperinsulinemic-euglycemic clamp

    Time frame: 9 hours

  3. 24 hour glycaemic profile

    continuous glucose monitor

    Time frame: 48 hours

  4. 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).

    Time frame: 1 hour

  5. 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.

    Time frame: 30 minutes

  6. 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.

    Time frame: 1 hour

  7. 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.

    Time frame: 1 hour

Other outcomes

  1. Effect of consumption of insulinogenic, CHO-rich drink post-exercise

    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

06

Study locations

1 site
  • University Maastricht
    Maastricht, Limburg 6229ER, Netherlands
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03405545
Lead sponsor
Maastricht University
Collaborators
Netherlands Organisation for Scientific Research
Responsible party
Sponsor
First posted
Jan 23, 2018
Start date
Mar 28, 2018
Primary completion
Oct 1, 2021
Completion
Oct 1, 2021
Last update
Sep 14, 2022

Study contacts

Matthijs Hesselink, Prof. PhD.
principal investigator · Maastricht University
Vera Schrauwen-Hinderling, PhD
principal investigator · Maastricht University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion