Overweight and ObesityNCT03405545
High Intensity Interval Training and Skeletal Muscle Insulin Sensitivity
A study testing High-intenstiy interval training in people with Overweight and Obesity, run by Maastricht University at 1 site in Netherlands.
Trial summary
This human intervention study will test if 12 weeks of supervised HIIT-based intervention improves skeletal muscle NOGD capacity in obese subjects. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- High-intenstiy interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Mar 2018to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Overweight and Obesity
- Being tested
- High-intenstiy interval training
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intenstiy interval trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| HIIT | Experimental | This group of subjects will perform High Intensity Interval training 3x/week for 12 weeks Receives: Behavioral: High-intenstiy interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-oxidative glucose disposal
Measured during a 2-step hyperinsulinemic-euglycemic clamp combined with indirect calorimetry
Measured: 9 hours
Secondary outcomes (7)
Skeletal muscle glycogen content
Assessed from skeletal muscle biopsies
Measured: 1 hour
Skeletal muscle insulin sensitivity
Measured during a 2-step hyperinsulinemic-euglycemic clamp
Measured: 9 hours
24 hour glycaemic profile
continuous glucose monitor
Measured: 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.
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).
Measured: 1 hour
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.
Measured: 30 minutes
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.
Measured: 1 hour
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start28 Mar 2018
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research
- Responsible party
- Sponsor
- Investigators
- Matthijs Hesselink, Prof. PhD., Principal investigator, Maastricht UniversityVera Schrauwen-Hinderling, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405545
- Sponsor's protocol ID
- NL62654.068.17
- Status last verified
- Sep 2022
- First submitted
- 14 Nov 2017
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Interval Training and Skeletal Muscle Insulin Sensitivity: Unraveling Health Effects and Underlying Mechanisms
- ClinicalTrials.gov ID
- NCT03405545
- Acronym / sponsor ID
- NL62654.068.17
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 1 group of participants that performs 12 weeks of HIIT with metabolic measurements before and after this training period
| Arm | Type | Receives |
|---|---|---|
| HIIT | Experimental | Behavioral: High-intenstiy interval trainingThis group of subjects will perform High Intensity Interval training 3x/week for 12 weeks |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intenstiy interval trainingHigh-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. | Behavioural | HIIT |
Primary outcome
Non-oxidative glucose disposal
Time frame: 9 hours
Measured during a 2-step hyperinsulinemic-euglycemic clamp combined with indirect calorimetry
7 secondary outcomes
Skeletal muscle glycogen content
Time frame: 1 hour
Skeletal muscle insulin sensitivity
Time frame: 9 hours
24 hour glycaemic profile
Time frame: 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
Metabolic Flexibility during exercise assessed by indirect calorimetry.
Time frame: 30 minutes
Ectopic Fat accumulation in the liver assessed by magnetic resonance spectroscopy.
Time frame: 1 hour
Maximal Acetylcarnitine formation in the upper-leg at rest and after exercise assessed by Magnetic Resonance Spectroscopy Scan
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthijs Hesselink, Prof. PhD. principal investigator
Maastricht University
Vera Schrauwen-Hinderling, PhD principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intenstiy interval training in people with Overweight and Obesity, run by Maastricht University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-oxidative glucose disposal (time frame: 9 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.