Clinical trial NCT03405545: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Maastricht University
Sponsor class: OTHER
Collaborators: name: Netherlands Organisation for Scientific Research
First posted: 2018-01-23
Enrollment: 19
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 1 group of participants that performs 12 weeks of HIIT with metabolic measurements before and after this training period
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Non-oxidative glucose disposal
timeFrame: 9 hours
Secondary outcomes:
measure: Skeletal muscle glycogen content
timeFrame: 1 hour
measure: Skeletal muscle insulin sensitivity
timeFrame: 9 hours
measure: 24 hour glycaemic profile
timeFrame: 48 hours
measure: Skeletal muscle mitochondrial function assessed by Magnetic Resonance Spectroscopy Scan using 31P-MRS methodology, based on the phosphocreatine (PCr) recovery kinetics after exercise.
timeFrame: 1 hour
measure: Metabolic Flexibility during exercise assessed by indirect calorimetry.
timeFrame: 30 minutes
measure: Ectopic Fat accumulation in the liver assessed by magnetic resonance spectroscopy.
timeFrame: 1 hour
measure: Maximal Acetylcarnitine formation in the upper-leg at rest and after exercise assessed by Magnetic Resonance Spectroscopy Scan
timeFrame: 1 hour
Other outcomes:
measure: Effect of consumption of insulinogenic, CHO-rich drink post-exercise
timeFrame: 12 weeks
Locations:
city: Maastricht
country: Netherlands
facility: University Maastricht
state: Limburg
Study officials:
affiliation: Maastricht University
name: Matthijs Hesselink, Prof. PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University
name: Vera Schrauwen-Hinderling, PhD
role: PRINCIPAL_INVESTIGATOR
References: