CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 42 enrolled
Drug / intervention
Exercise in normoxia +3 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05094505
NCT05094505N/ACompleted

Isolated and Combined Effect of a Low Carbohydrate Diet and Chronic Exercise Exposure to Hypoxia on Glycaemic Control and Cardiovascular Risk Factors in Patients With Type 2 Diabetes

Universidade do Porto·interventional·Posted Oct 26, 2021·Updated Jul 19, 2023

In Brief

A clinical study evaluating Exercise in normoxia, Control diet, and 2 other interventions for Carbohydrate and 3 related conditions. Completed, enrolled 42 participants across 2 sites.

Detailed Summary

The purpose of this study is to determine the effects of isolated chronic exercise in hypoxia and combined exercise in hypoxia with a low carbohydrate diet on hypoxia-induced transcription factor (HIF1-α); glycaemic control and cardiovascular risk factors in patients with type 2 diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPortugal

Timeline

N/ACompletedFinished
20222023202420252026
First PostedOct 26, 2021
Enrollment StartOct 1, 2021
Primary CompletionJul 18, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 4.7 years ago

Interventions

Exercise in normoxiaother

Exercise at sea level, 3 sessions per week, during a 8-week period intervention and will consist in 60 min on an ergometer, of continuous moderate and high intensity interval training. . All exercise testing and training sessions will be carried out at the same time of day (± 2 hours) and visits will be separated by at least 48h of recovery.

Control dietother

Control diet: diet plans will be individualized and energy-content prescriptions will be constant throughout the study to maintain the isocaloric control between diets. The planned macronutrient compositions will be 20% of energy from fat, 20% from protein and 60% from carbohydrates for the low-fat diet during the 8 weeks. Diets emphasis on low-glycemic index foods and limited saturated fat to 10% of energy. Participants will meet individually with a dietitian two times for 8 weeks and should start the dietary intervention along with the intervention with exercise.

Exercise in hypoxiaother

Exercise at 3000m altitude, 3 sessions per week, during a 8-week period intervention and will consist in 60 min on an ergometer, of continuous moderate and high intensity interval training. . All exercise testing and training sessions will be carried out at the same time of day (± 2 hours) and visits will be separated by at least 48h of recovery.

Low carbohydrate dietother

Low carbohydrate diet: diet plans will be individualized and energy-content prescriptions will be constant throughout the study to maintain the isocaloric control between diets. The planned macronutrient compositions will be 40% of energy from fat, 20% from protein and 40% from carbohydrates for the low-fat diet during the 8 weeks. Diets emphasis on low-glycemic index foods and limited saturated fat to 10% of energy. Participants will meet individually with a dietitian two times for 8 weeks and should start the dietary intervention along with the intervention with exercise.