Impact of Eccentric Training in Hypoxia With Creatine on Metabolic Control and VO2max in Patients With Type 1 Diabetes

Impact of Eccentric Training Conducted in the Conditions of Normobaric Hypoxia, Normoxia and Creatine Supplementation on Metabolic Control, Muscle Strength Level, Maximum Oxygen Consumption (VO2max) in Patients With Type 1diabetes Mellitus

Exercise plays an important role in treatment of diabetes. In recent years exercise training in normobaric hypoxia is used in training programs for athletes and in rehabilitation and also commercially. The aim of the study is to assess the impact of eccentric training conducted in conditions of normobaric hypoxia or normoxia and creatine supplementation on metabolic control: profile and stability of glucose concentration, HbA1c value, hypoglycemia and insulin demand, as well as the level of muscle strength, VO2max and anthropometric parameters

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: hypoxia; Dietary supplement: creatine supplementation; Dietary supplement: no creatine supplementation; Behavioral: normoxia

Detailed Description

People with type 1 diabetes benefit from training in normobaric hypoxia - the composition of the air in the training room is: 15.4% oxygen 84.7% nitrogen, which corresponds to hypoxia at an altitude of 2,500 m above sea level. Hypoxia leads to the production of the hypoxia-inducible transcription factor HIF-1, which is a regulator of the expression of many genes responsible for angiogenesis, muscle hypertrophy and glucose stability.

Before starting the10 - week training program all participants will undergo preliminary examination by a cardiologist during which echocardiography and ECG will be conducted. Then the incremental exercise test and muscle strength test will be performed to determine aerobic capacity (VO2max) and select individual weights to train for each participant.

Patients enrolled to the study will be randomly assigned to one of the following 2 groups (training under normoxia or hypoxia conditions) and subgroups (with and without supplementation of creatine).

Randomization will be carried out in blocks of 4 people.

Training sessions will take place with the assistance of a personal trainer in the Hypoxia Laboratory and the Muscle Strength and Power Laboratory of Academy of Physical Education in Katowice twice a week for 60 minutes for a period of 10 weeks. The subjects will complete the same eccentric training program with individually selected weights.

Within whole training period glucose level will be monitored via Flash Glucose Monitoring system (Free Style Libre2). During training sessions concentration of asprosin, irisin, GH, IGF-1 within blood serum immediately before and afrer the first and last training will be assessed.

At baseline and after 10 weeks blood count, ALT, AST, creatinine, GFR, HbA1c, ACR (albumin/creatinine ratio) in a random urine sample, body weight, BMI, waist-hip circumference, body composition, quality of life according to the EQ-Worksheet questionnaire, daily insulin requirement, incremental exercise test, muscle strength test (1RM) will be investigated among all participants.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marta Wróbel, MD,PhD; Phone Number: +46606873060; Email: mwrobel@sum.edu.pl
• Study Contact Backup: Name: Paula Nowocień, MD; Phone Number: 48695219960; Email: paula.nowocien@protonmail.com

Study Locations

• Poland
  • Silesia
    • Zabrze, Silesia, Poland, 41-800
      • Recruiting
      • Department of Internal Diseases, Diabetology and Cardiometabolic Disorders, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Poland
      • Contact: Marta Wróbel, PhD; Phone Number: 48606873060; Email: mwrobel@sum.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• type 1 diabetes of at least 10 years duration,
• low physical activity,
• BMI:20-31 kg/m2,
• treated with multiple insulin injections (at least 4 daily) or insulin pump (continuous subcutaneous insulin infusion [CSII]),
• negative ECG exercise test,
• HbA1c ≤ 8,0%,
• high knowledge about functional insulin therapy, carbohydrate counting and diabetes management during exercise,
• experience in use of FreeStyleLibre2 (Flash Glucose Monitoring System, Abbott),
• Informed consent to participate in research signed by enrolled subjects

Exclusion Criteria:

• HbA1c > 8,0%,
• advanced complications of diabetes [pre-proliferative or proliferative retinopathy, and previous laser therapy, microalbuminuria or overt nephropathy, autonomic neuropathy (including lack of elevated heart rate during physical activity)],
• patients physically active (regular physical activities more than once a week),
• positive ECG exercise test,
• history of cardiovascular event or coronary heart disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1. exercise in hypoxia with creatine supplementation; training program in normobaric hypoxic chamber set to contain equivalent to an altitude of 2500 meters above sea level (indoor air composition: 15,4% of O2 and 84,7% of N); with creatine supplementation	Behavioral: hypoxia; eccentric training program conducted within normobaric hypoxic chamber; Dietary supplement: creatine supplementation; 5g of creatine per day
Experimental: 2. exercise in hypoxia without creatine supplementation; training program in normobaric hypoxic chamber set to contain equivalent to an altitude of 2500 meters above sea level (indoor air composition: 15,4% of O2 and 84,7% of N); without creatine supplementation	Behavioral: hypoxia; eccentric training program conducted within normobaric hypoxic chamber; Dietary supplement: no creatine supplementation; no creatine supplementation
Experimental: 3. exercise in normoxia with creatine supplementation; the same training program in normoxic conditions; with creatine supplementation	Dietary supplement: creatine supplementation; 5g of creatine per day; Behavioral: normoxia; eccentric training program conducted within normoxic conditions
Experimental: 4.exercise in normoxia without creatine supplementation; the same training program in normoxic conditions; without creatine supplementation	Dietary supplement: no creatine supplementation; no creatine supplementation; Behavioral: normoxia; eccentric training program conducted within normoxic conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic control of diabetes	HbA1c (%, mmol/mol)	before and after 10 weeks
Time in range	TIR- percentage of time with blood glucose in a target range: 70-180 mg/dl (%)	before and after 10 weeks
Time below range	TBR - percentage of time with blood glucose levels<70 mg/dl (%)	before and after 10 weeks
Maximum oxygen consumption (VO2max)	measured during incremental exercise test	before and after 10 weeks

Collaborators and Investigators

• Sponsor: Silesian Centre for Heart Diseases
• Investigators: Study Chair: Krzysztof Strojek, Prof., Medical University of Silesia in Katowice

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: exercise; hypoxia; type 1 diabetes; eccentric exercise
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Signs and Symptoms, Respiratory; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoxia
• Other Study ID Numbers: Hypoxia-Exercise-DiabetesT1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No