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

NCT06345612 | Recruiting

• 1 other identifier: Hypoxia-Exercise-DiabetesT1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 1 Diabetes

Keywords

exercise; eccentric exercise; hypoxia; type 1 diabetes

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

1. exercise in hypoxia with creatine supplementation

EXPERIMENTAL

* 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; Dietary Supplement: creatine supplementation

2. exercise in hypoxia without creatine supplementation

EXPERIMENTAL

* 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; Dietary Supplement: no creatine supplementation

3. exercise in normoxia with creatine supplementation

EXPERIMENTAL

* the same training program in normoxic conditions * with creatine supplementation

Behavioral: normoxia; Dietary Supplement: creatine supplementation

4.exercise in normoxia without creatine supplementation

EXPERIMENTAL

* the same training program in normoxic conditions * without creatine supplementation

Behavioral: normoxia; Dietary Supplement: no creatine supplementation

Interventions

hypoxia BEHAVIORAL

eccentric training program conducted within normobaric hypoxic chamber

1. exercise in hypoxia with creatine supplementation; 2. exercise in hypoxia without creatine supplementation

normoxia BEHAVIORAL

eccentric training program conducted within normoxic conditions

3. exercise in normoxia with creatine supplementation; 4.exercise in normoxia without creatine supplementation

creatine supplementation DIETARY_SUPPLEMENT

5g of creatine per day

1. exercise in hypoxia with creatine supplementation; 3. exercise in normoxia with creatine supplementation

no creatine supplementation DIETARY_SUPPLEMENT

no creatine supplementation

2. exercise in hypoxia without creatine supplementation; 4.exercise in normoxia without creatine supplementation

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Silesian Centre for Heart Diseases: lead

Study Sites (1)

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

Zabrze, Silesian Voivodeship, 41-800, Poland

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity; Hypoxia

Interventions

Creatine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Krzysztof Strojek, Prof.

  Medical University of Silesia in Katowice

  STUDY CHAIR

Central Study Contacts

Marta Wróbel, MD,PhD

CONTACT

+46606873060; mwrobel@sum.edu.pl

Paula Nowocień, MD

CONTACT

48695219960; paula.nowocien@protonmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: April 3, 2024
• Study Start: November 15, 2023
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-02

Locations

PL (1)