Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02642705
Other study ID # 2014-A01482-45
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date April 2021

Study information

Verified date March 2020
Source University Hospital, Grenoble
Contact Samuel Verges, PhD
Phone 0476766860
Email sverges@chu-grenoble.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The present study aims at evaluating the effect of two innovative treatment strategies in obese patients: high intensity interval training and hypoxic conditioning. Obese patients will be randomized in groups performing high intensity interval training, constant load training, hypoxic conditioning or placebo normoxic conditioning for 8 weeks. The effects of the interventions will be measured regarding exercise tolerance, blood pressure, body composition, metabolic status.


Description:

120 obese patients will be randomized to 6 intervention groups. Each group will follow an 8-week intervention (3 session per week) with either high intensity interval training in normoxia or hypoxia, constant load exercise training in normoxia or hypoxia, hypoxic or normoxic (placebo) conditioning at rest. Exercise capacity, metabolic status, blood pressure, vascular function and physical activity will be assessed before and after the intervention.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date April 2021
Est. primary completion date April 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- BMI between 27 and 35 kg/m²

- Physical activity <2 hours/week

- No chronic disease or treatment able to interfere with inflammation and metabolic perturbatiosn associated with obesity

Exclusion Criteria:

- Diabetes mellitus treated with insulin

- Auto-immune or inflammatory diseases requiring long term therapy

- Unstable dysthyroidism

- Bariatric surgery within the past 18 months

- Tumoral, inflammatory, infectious, cardiac, respiratory, kidney, digestive disease

- Untreated sleep apnea

Study Design


Related Conditions & MeSH terms


Intervention

Other:
High intensity interval training N
Exercise training and ambient air breathing
High intensity interval training H
Exercise training and hypoxic breathing
Constant load exercise training N
Exercise training and ambient air breathing
Constant load exercise training H
Exercise training and hypoxic breathing
Hypoxic conditioning at rest
Hypoxic breathing at rest
Normoxic conditioning at rest
Normoxic breathing at rest (placebo)

Locations

Country Name City State
France Grenoble University Hospital Grenoble Rhone Alpes

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (2)

Verges S, Chacaroun S, Godin-Ribuot D, Baillieul S. Hypoxic Conditioning as a New Therapeutic Modality. Front Pediatr. 2015 Jun 22;3:58. doi: 10.3389/fped.2015.00058. eCollection 2015. Review. — View Citation

Weston KS, Wisløff U, Coombes JS. High-intensity interval training in patients with lifestyle-induced cardiometabolic disease: a systematic review and meta-analysis. Br J Sports Med. 2014 Aug;48(16):1227-34. doi: 10.1136/bjsports-2013-092576. Epub 2013 Oct 21. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Maximal exercise capacity Maximal oxygen consumption during an incremental exercise test 8 weeks
Secondary Metabolic status Blood lipids, glycemia, HOMA index, oxydative stress and inflammatory status 8 weeks
Secondary Body composition MRI fat free mass and adipose tissue measurements 8 weeks
Secondary Blood pressure 24 h ambulatory blood pressure mesurement 8 weeks
Secondary Vascular function Post-ischemic hyperemia (Endo-Pat) and pulse wave velocity 8 weeks
Secondary Physical activity Spontaneous physical activity measured by accelerometry 8 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2