NCT04443777

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

Status unknown Phase 4 Last updated 23 June 2020

What this trial tests

Phase 4 trial testing Resistance Training in Resistance Training in 44 participants. Status unknown.

Timeline

1 June 2020

Primary endpoint
1 August 2020

1 September 2020

Quick facts

Lead sponsor	Instituto de Cardiologia do Rio Grande do Sul
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	other
Enrollment	44
Start date	1 June 2020
Primary completion	1 August 2020
Estimated completion	1 September 2020
Sites	1 location across Brazil

Drugs / interventions tested

• Resistance Training

Conditions studied

• Resistance Training — all drugs for Resistance Training →
• Sport Performance — all drugs for Sport Performance →
• Muscle Recovery — all drugs for Muscle Recovery →
• Hypoglycemic Agents — all drugs for Hypoglycemic Agents →

Sponsor

Instituto de Cardiologia do Rio Grande do Sul — full company profile →

Who can join

Adults 20 to 30, male only, with Resistance Training or Sport Performance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Modified-release gliclazide acutely improves recovery but causes undesirable blood glucose decrease after a resistance exercise session in healthy adults: a pilot study for a randomized clinical trial.
   Martins JB, Zanella D, Nunes RB, Collado PS, et al · · 2024 · cited 1× · PMID 39420894 · DOI 10.20945/2359-4292-2023-0381
2. Gliclazide Enhances Exercise Performance and Recovery of Muscle Strength in Healthy Trained Individuals: A Randomized Controlled Trial.
   Martins JB, Dipp T, Schaan BD, Lehnen AM. · · 2026 · PMID 41818607 · DOI 10.1002/ejsc.70155
3. Gliclazide enhances exercise performance and recovery of muscle strength in healthy trained individuals: a randomized controlled trial
   Martins JB, Dipp T, Schaan BD, Lehnen AM. · · 2024 · DOI 10.21203/rs.3.rs-4450743/v1