Exercise as a Tool for Studying the Mechanisms and Applicability of Glycemic Variability

NCT02262208 | Unknown DMC

• 1 other identifier: 120148
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The aim this study is characterize glycemic variability using linear and nonlinear mathematical tools, under basal conditions and in response to specific protocols acute exercise that evoke oxidative stress and inflammation in healthy subjects and type 2 diabetes patients. For this purpose, the sample size will consist of 37 individuals healthy and 32 without type 2 diabetes mellitus wore a CGMS during 3 days. Participants randomly performed aerobic and eccentric sessions, both in the morning (24h after CGMS placement), and at least 7 days apart. Glucose variability was evaluated by glucose standard deviation, glucose variance, mean amplitude of glycemic excursions (MAGE), and glucose coefficient of variation (conventional methods) as well as by spectral and symbolic analysis (non-conventional methods). Physiological mechanisms altered by exercise protocols (Human Soluble Interleukin-6 and Glutathione), will be measured in blood samples.

Conditions

Type 2 Diabetes

Keywords

Glycemic variability, exercise, diabetes

Outcome Measures

Primary Outcomes (1)

• Glycemic variability by continuous glucose monitoring system

  Will be assessed conventional and non-conventional methods to analyze glucose variability derived from multiple measurements performed with continuous glucose monitoring system (CGMS).Subjects will be admitted to the laboratory in the morning at approximately 9:00 a.m., 24 h before the exercise session, when the glucose sensor (Sof-SensorTM, Medtronic Mini-Med, Northridge, USA) will be inserted subcutaneously. The sensor is a glucose oxidase based platinum electrode that is inserted through a needle into the subcutaneous tissue of the anterior abdominal wall, using a spring-loaded device (Senserter, Medtronic, Northridge, USA). Glucose profiles will be collected the day before (day 1), the day of (day 2), and the day following (day 3) and 40 min of exercise. Each sensor will be used continuously for up to 72 h.

  The monitor that analyzes the data every 10s and reports average values every 5 min, totalizing 288 readings per day. Glucose profiles will be collected the day before (day 1), the day of (day 2), and the day following (day 3) of 40 min of both exercise.

Secondary Outcomes (1)

• Oxidative stress

  10 minutes before the exercise sessions and 10 minutes after the exercise sessions.

Study Arms (2)

Patients with type 2 diabetes

OTHER

Other: Aerobic Exercises; Other: Eccentric Exercise; Device: Continuous glucose monitoring system (Guardian, Medtronic, Northridge, USA)

Healthy

OTHER

Other: Aerobic Exercises; Other: Eccentric Exercise; Device: Continuous glucose monitoring system (Guardian, Medtronic, Northridge, USA)

Interventions

Aerobic Exercises OTHER

Exercise intensity for each individual by a heart rate monitor (Polar F1 TM, Polar Electro Oy, Helsinki, Finland), and a Borg 0-10 scale used to register individuals' perceived exertion every 5 minutes throughout the experimental sessions. Aerobic session will consist of 40 min of lower limb bicycle at 70% of the peak heart rate, as determined in the incremental exercise test.

Healthy; Patients with type 2 diabetes

Eccentric Exercise OTHER

Eccentric session will consist of 40 min of one lower -limb exercises (leg press) with 6 sets of 10 repetitions at 120% of 1-RM.

Healthy; Patients with type 2 diabetes

Continuous glucose monitoring system (Guardian, Medtronic, Northridge, USA) DEVICE

Subjects will be admitted to the laboratory in the morning at approximately 9:00 a.m., 24 h before the exercise session, when the glucose sensor (Sof-SensorTM, Medtronic Mini-Med, Northridge, USA) will be inserted subcutaneously. The sensor is a glucose oxidase based platinum electrode that is inserted through a needle into the subcutaneous tissue of the anterior abdominal wall, using a spring-loaded device (Senserter, Medtronic, Northridge, USA). Glucose profiles will be collected the day before (day 1), the day of (day 2), and the day following (day 3) and 40 min of exercise. Each sensor will be used continuously for up to 72 h.

Healthy; Patients with type 2 diabetes

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes Male and female 18-65 years old

You may not qualify if:

• Chronic kidney failure; Limb amputation Diabetic proliferative retinopathy; Regular physical training; Severe autonomic neuropathy; Diabetic nephropathy established; Coronary artery disease; Heart failure; Uncontrolled hypertension Treatment of insulin

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

RECRUITING

Related Publications (2)

• Rahman I, Kode A, Biswas SK. Assay for quantitative determination of glutathione and glutathione disulfide levels using enzymatic recycling method. Nat Protoc. 2006;1(6):3159-65. doi: 10.1038/nprot.2006.378.

  PMID: 17406579 BACKGROUND

• Figueira FR, Umpierre D, Bock PM, Waclawovsky G, Guerra AP, Donelli A, Andrades M, Casali KR, Schaan BD. Effect of exercise on glucose variability in healthy subjects: randomized crossover trial. Biol Sport. 2019 Jun;36(2):141-148. doi: 10.5114/biolsport.2019.83006. Epub 2019 Feb 22.

  PMID: 31223191 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity; Diabetes Mellitus

Interventions

Exercise; Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Beatriz D'Agord Schaan

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: October 13, 2014
• Study Start: January 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 15, 2014

Record last verified: 2014-10

Locations

BR (1)