An interventional study of HIIT-LV and CAE in Metabolic Syndrome and Insulin Resistance, sponsored by Universidad de Antioquia. Completed at 1 site in Colombia. Open to participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-01.
Sponsored by Universidad de Antioquia · Not applicable, Interventional, and Treatment
The primary objective of the study is to compare the efficacy of an intervention with high-intensity interval, low volume training (HIIT-LV) or continuous aerobic exercise (CAE) on insulin resistance, insulin sensitivity and percentage of pancreatic β-cell function in adults with metabolic syndrome (MS).
The secondary objective is to compare the efficacy of an intervention with HIIT-LV or CAE on glycosylated hemoglobin, mass and muscle fibre type composition of right thigh and plasma levels of musclin and apelin in adults with MS.
The investigators hypothesized that HIIT-LV is more effective in decreasing insulin resistance and glycosylated hemoglobin and plasma concentrations of musclin and increasing plasma concentrations of apelin, and both mass and muscle fibre type I percentage in thigh, than CAE.
This study is a randomized, controlled, masked (single blind, outcomes assessor) clinical trial, with allocation by the minimization method, with two parallel groups and intention of superiority. It was designed to test the hypothesis that a 12-week program of HIIT-LV, yields larger beneficial effects on insulin resistance, skeletal muscle composition and endocrine function than CAE.
Although aerobic exercise increases cardio-respiratory capacity, modifies risk factors and decreases mortality risk, there is currently controversy and gaps in knowledge over the efficacy of more intense and low-volume physical activities on muscle metabolism in patients with metabolic disorders.
The primary outcome will be the insulin resistance, insulin sensitivity and percentage of pancreatic β-cell function. The secondary outcomes will be the glycosylated hemoglobin, mass and muscle fibre type composition of thigh and plasma levels of musclin and apelin. Assessments will be made before and after the 12-week program. Calculations based on previously results (difference mean 10% and SD 15%) suggest that a total number of 60 patients randomized 1:1 (30 in each group) to the two intervention groups is sufficient to detect larger beneficial effects with HIIT-LV with a p-value of 0.05 (two-sided test) and statistical power of 0.80 (primary endpoint is insulin sensitivity).
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →Universidad de Antioquia is the lead sponsor of 79 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: HIIT-LV
Behavioral: CAE
Supervised endurance treadmill training as walking/running "uphill", 3 times/week during 12 weeks starting at 85-90% of previously determined maximum oxygen consumption (VO2 max). Warm-up 3 min at 30% of VO2 max, 3 min cool-down. Progression in intensity every 3erd week.
Supervised moderate intensity treadmill training, 3 times/week for 12 weeks starting at 70% of VO2 max. Warm-up 3 min at 30% of VO2 max, 3 min cool-down. Progression in intensity every 3erd week.
Insulin sensitivity
Using HOMA model (units as percentages of a normal reference population)
Time frame: 12-week
Insulin resistance
Using HOMA model (arbitrary units)
Time frame: 12-week
Pancreatic β-cell function
Using HOMA model (units as percentages of a normal reference population)
Time frame: 12-week
Glycosylated hemoglobin
Using blood tests (%)
Time frame: 12-week
Mass muscle of right thigh
Using dual energy x-ray absorptiometry (DEXA) (kg/m2)
Time frame: 12-week
Muscle fibre type composition of right thigh
Using carnosine quantification by hydrogen magnetic resonance spectroscopy (1H-MRS) (% fibre type I)
Time frame: 12-week
Musclin
Using plasma levels of musclin (pg/mL)
Time frame: 12-week
Apelin
Using plasma levels of apelin (pg/mL)
Time frame: 12-week
Plan to share: Yes
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universidad de Antioquia