Analysis of Ergogenic Potential and Risks Associated With Acute and Chronic Use of Sulphonylureas on Physical Exercise

Summary

This study have like aim to examine whether insulin secretagogues have a potential ergogenic effect leading to a better exercise performance and post-exercise recovery in healthy individuals after a resistance training session. METHODS: This is a randomized, double-blind, placebo-controlled, clinical trial. The sample will consist of 44 men. Subjects will be randomly allocated (block randomization, www.randomizer.org) to the following groups: placebo (PFG, n=22) and sulphonylurea (GFS, n=22). The study will consist of 3 visits 7 days apart. On visit 1 the participants will ask to sign an informed consent form and will carry out medical evaluation with anthropometric assessment. At that visit they will perform a one-repetition maximum test of the upper limbs by using the horizontal bench press and of the lower limbs by using the 45º leg press. On visit 2, they will perform a second round of similar 1-RM tests to determine workloads for the study session \[sulphonylurea (gliclazide) vs. placebo\]. The experimental exercise session will be held on visits 3. Gliclazide modified release 60 mg (Diamicron® MR) or placebo (starch, sodium lauryl sulfate and Aerosil) will be orally administered as matched capsules (same color, flavor, smell and size) 8 hours before the beginning of exercise session, double-blind. In the experimental session, first, warm-up on the bench press and leg press, both with workload at 50% of 1-RM will be carried out. After a 2-minute rest, the resistance training session will be started. It will consist of 4 sets of bench press and leg press exercises at 65% of 1-RM with maximum repetitions until concentric failure. The bench press exercises will be followed by the leg press exercises with no interval between them. A 2-minute interval will allowed after each series of exercises. Measurements for heart rate (HR) and Visual Analogue Scale (VAS) for Pain will be taken before, between each series of exercises and 24 and 48 hours after session. Venous blood samples will be obtained before, immediately after, 24 and 48 hours after, for determining serum levels of creatine kinase isoenzyme MM and lactate dehydrogenase. Capillary blood for glucose determination will be collected from the digital pulp using a glucometer before and immediately after. Resistance training volume will be calculated for each type of exercise as well as total training volume for each session as a product of exercise workload and number of series and repetitions.

Conditions

• Resistance Training
• Sport Performance
• Muscle Recovery
• Hypoglycemic Agents
• Randomized Controlled Trial

Interventions

OTHER

Resistance Training

Both groups will perform the resistance training protocol that will consist of a warm-up on the bench press and leg press, both with workload at 50% of 1-RM. After a 2-minute rest, the resistance training session will be started. It will consist of 4 sets of bench press and leg press exercises at 65% of 1-RM with maximum repetitions until concentric failure, with the execution speed of 2x2. The bench press exercises will be followed by the leg press exercises with no interval between them. A 2-minute interval will allowed after each series of exercises.

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

30 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-06-01

Primary Completion

2020-08-01

Completion

2020-09-01

Countries

• Brazil

Study Locations