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

NCT04443777 | Unknown Phase 4 DMC

• 1 other identifier: 5649/19
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Resistance Training Performance

  The performance of resistance training will be measured by the volume of training. This measure is obtained by the total load performed by the subject, measured in kilograms (Kg), being a product of the number of repetitions x the number of series and the load lifted by repetition (volume of training (Kg) = workload (Kg) x Repetition (nº) x Series (nº)). (18. Correa CS, Cadore EL, Martins JB, Silva ER, Pinto RS, Oliveira AR, Kruel LFM. The effects of ibuprofen on muscle performance, worload and plasma creatine kinase during strength training session. Medicina Sportiva. 2012;16(1):17-21).

  one week

• Muscle Recovery Marker 1

  Serum levels of creatine kinase isoenzyme MM (CK-MM)

  one week

• Muscle Recovery Marker 2

  Serum levels of lactate dehydrogenase (LDH)

  one week

Secondary Outcomes (2)

• Subjective Perception Pain

  one week

• Blood Glucose Concentration

  one week

Study Arms (2)

Sulphonylurea Group

ACTIVE COMPARATOR

Gliclazide 60 mg (Diamicron® MR) will be orally administered as matched capsules (same color, flavor, smell and size) 8 hours before the beginning of exercise session.

Other: Resistance Training

Placebo Group

PLACEBO COMPARATOR

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.

Other: Resistance Training

Interventions

Resistance Training OTHER

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.

Placebo Group; Sulphonylurea Group

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• continuously resistance-trained for 2 years or more
• minimum frequency of 3 weekly sessions
• preceding 6 months

You may not qualify if:

• self-reported acute or chronic use of drugs including anabolic androgenic steroids, anti-inflammatory drugs, beta-blockers and exogenous insulin for the last 12 months
• alcohol intake within 72 hours of the study intervention
• injuries to bones and muscles preventing physical exercise
• non-adherence to dietary recommendations as instructed by the research team

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead

Study Sites (1)

Fundação Universitária de Cardiologia/ Instituto de Cardiologia

Porto Alegre, Rio Grande do Sul, 90040-371, Brazil

RECRUITING

Related Publications (1)

• Martins JB, Zanella D, Nunes RB, Collado PS, Lehnen AM. 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. Arch Endocrinol Metab. 2024 Jul 30;68:e230381. doi: 10.20945/2359-4292-2023-0381. eCollection 2024.

  PMID: 39420894 DERIVED

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Jocelito B Martins, MSc

CONTACT

+55 51 9999-76244; martins.jocelito@gmail.com

Alexandre M Lehnen, PhD

CONTACT

+55 51 9997-68092; amlehnen@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: This is a randomized, double-blind, placebo-controlled, parallel-group clinical trial.

Study Record Dates

• First Submitted: May 23, 2020
• First Posted: June 23, 2020
• Study Start: June 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)