Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04443777
Status:
UNKNOWN
Last Update Posted:
2020-06-23
First Post:
2020-05-23
Brief Title:
Analysis of Ergogenic Potential and Risks Associated With Acute and Chronic Use of Sulphonylureas on Physical Exercise
Sponsor:
Instituto de Cardiologia do Rio Grande do Sul
Organization:
Instituto de Cardiologia do Rio Grande do Sul
Study Overview
Official Title:
Analysis of Ergogenic Potential and Risks Associated With Acute and Chronic Use of Sulphonylureas on Physical Exercise
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 wwwrandomizerorg to the following groups placebo PFG n22 and sulphonylurea GFS n22 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
Detailed Description:
The use of performance-enhancing drugs is a major area of concern for high-performance athletes because it may lead to serious health problems It is also quite concerning that these substances are also widely used without guidance among non-athletes for faster results and aesthetic reasons Several substances used for doping in sports have well-established ergogenic and side effects Studies have shown that insulin is used for its anabolic effects mostly among recreational and professional weightlifters and bodybuilders Currently insulin and its analogs are on the WADA list of prohibited substances for their anabolic effects mostly in muscle tissues and side effects However a class of drugs known as insulin secretagogues are used by some athletes to enhance performance Few studies have examined the potential effects of insulin secretagogues especially sulfonylureas on exercise performance and post-exercise recovery among athletes as well as their potential side effects Despite insufficient data supporting the use of insulin secretagogues as ergogenic supplement well as well its associated risks these substances have been empirically used for both acute and chronic effects among professional athletes and non-athletes Thus the present 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 young adults healthy and experienced in strength training and who meet the inclusion and exclusion criteria specified The sample calculation was determined by a pilot study conducted with 10 subjects with strength performance as the primary outcome using drug Gliclazide or placebo taking into account a statistical power of 95 and a significance level of 5 For this purpose the GPower 31was used Subjects will be randomly allocated block randomization wwwrandomizerorg to the following groups placebo PFG n22 and sulphonylurea GFS n22 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 sessions sulphonylurea gliclazide vs placebo The experimental exercise session will be held on visit 3 The participants will ask to follow a personalized food intake plan prescribed by a skilled provider in the 24 hours proceeding both sessions Gliclazide modified release MR or placebo will be orally administered as matched capsules same color flavor smell and size 8 hours before the beginning of exercise session Gliclazide 60 mg Diamicron MR or placebo starch sodium lauryl sulfate and Aerosil will administered double-blind Upon arrival at the study site the participants will consum a pre-workout snack The experimental protocol will start 30 minutes later First warm-up on the bench press and leg press both with workload at 50 of 1-RM wil 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 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 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 session for determining serum levels of creatine kinase isoenzyme MM and lactate dehydrogenase using a colorimetric enzymatic assay Capillary blood for glucose determination will be collected from the digital pulp using a glucometer before and immediately after session At the end of exercise session a custom will be offered to prevent potential hypoglycemic events 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 The data will be present as means standard deviation SD Repeated measures ANOVA Two Way using Bonferroni post-hoc tests will be used for comparisons between the study drug and placebo over time All data analyses will be carried out using SPSS 230 at a significance level of p005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None