High Intensity Interval Training and Skeletal Muscle Insulin Sensitivity

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03405545
• Other study ID #: NL62654.068.17
• Status: Completed
• Phase: N/A
• Start date: March 28, 2018
• Est. completion date: October 1, 2021

Study information

• Verified date: September 2022
• Source: Maastricht University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insulin Resistance
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• High-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.

Locations

Country	Name	City	State
Netherlands	University Maastricht	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University	Netherlands Organisation for Scientific Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	12 weeks
Primary	Non-oxidative glucose disposal	Measured during a 2-step hyperinsulinemic-euglycemic clamp combined with indirect calorimetry	9 hours
Secondary	Skeletal muscle glycogen content	Assessed from skeletal muscle biopsies	1 hour
Secondary	Skeletal muscle insulin sensitivity	Measured during a 2-step hyperinsulinemic-euglycemic clamp	9 hours
Secondary	24 hour glycaemic profile	continuous glucose monitor	48 hours
Secondary	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).	1 hour
Secondary	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.	30 minutes
Secondary	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.	1 hour
Secondary	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.	1 hour