Overweight and Obesity Clinical Trial
Official title:
High Intensity Interval Training and Skeletal Muscle Insulin Sensitivity: Unraveling Health Effects and Underlying Mechanisms
Verified date | September 2022 |
Source | Maastricht University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This human intervention study will test if 12 weeks of supervised HIIT-based intervention improves skeletal muscle NOGD capacity in obese subjects.
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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | University Maastricht | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University | Netherlands Organisation for Scientific Research |
Netherlands,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT03994419 -
PErioperAtive CHildhood ObesitY
|
||
Recruiting |
NCT05354245 -
Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)
|
N/A | |
Completed |
NCT03602001 -
Attentive Eating for Weight Loss
|
N/A | |
Recruiting |
NCT06269159 -
The Power of 24-hour: Co-designing Intervention Components
|
||
Completed |
NCT03377244 -
Healthy Body Healthy Souls in the Marshallese Population
|
N/A | |
Completed |
NCT02996864 -
Location-based Smartphone Technology to Guide College Students Healthy Choices Ph II
|
N/A | |
Completed |
NCT04647149 -
Effects of Early and Delayed Time-restricted Eating in Adults With Overweight and Obesity
|
N/A | |
Terminated |
NCT03914066 -
A Group-based Treatment of Overweight and Obesity in Primary Care
|
N/A | |
Completed |
NCT03685656 -
Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers
|
N/A | |
Completed |
NCT05051579 -
A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities
|
Phase 2 | |
Completed |
NCT04611477 -
Effect of Synbiotic 365 on Body Composition in Overweight and Obese Individuals
|
N/A | |
Active, not recruiting |
NCT05330247 -
Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study
|
N/A | |
Completed |
NCT03599115 -
Effects of Inhibitory Control Training in Eating Behaviors
|
N/A | |
Recruiting |
NCT05938894 -
Train Your Brain - Executive Function
|
N/A | |
Recruiting |
NCT06094231 -
Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study
|
N/A | |
Recruiting |
NCT05987306 -
A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss
|
N/A | |
Completed |
NCT03792685 -
Looking for Personalized Nutrition for Obesity/Type 2 Diabetes Mellitus Prevention
|
N/A | |
Completed |
NCT05055362 -
Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study
|
N/A | |
Completed |
NCT04520256 -
Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy
|
Phase 2/Phase 3 | |
Completed |
NCT04979234 -
A Single Centre, Prospective Feasibility Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) on Severe Obstructive Sleep Apnea Syndrome
|
N/A |