Optimization of Exercise Protocol for Prediabetic Population in Postprandial State

NCT06656377 | Completed DMC

• 2 other identifiers: DIR/KMU-EB/OE/00060Ref No. 20-16057/NRPU/R&D/HEC
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The core purpose of the project is to find out optimal exercise protocol for control of hyperglycemia and insulin resistance in prediabetic. The results of the study will increase the current understandings of how exercise can be used in the most efficient manner to extract the maximum possible benefits and enhance adherence in best scientific manner possible.

Conditions

Prediabetes; Exercise; Blood Glucose Profile; Lipid Profile; Optimization; Time

Keywords

prediabetes; Exercise; Optimization; Time; Intensity; Duration

Outcome Measures

Primary Outcomes (15)

• Exercise timings and Metabolic health: Targeting Blood glucose in Adults with Prediabetes post meal

  This study aims to investigate the effects of varied exercise timing post-meal (30 min, 60 min, 90 min, and 120 minutes) on blood glucose levels. The Blood glucose levels will be measured at fasting, pre-exercise, 30 and 60 minutes post-exercise in mg/dL, using a standard glucose meter.

  8 months

• Exercise Timing and Metabolic health: Targeting Blood Insulin in Adults with Prediabetes post meal

  his study aims to investigate the effects of varied exercise timing post-meal (30 min, 60 min, 90 min and 120 minutes) on Insulin levels. The Insulin levels will be measured at baseline, pre-exercise, 30 and 60 minutes post exercise, in the prediabetic population, to identify which intensity is the most effective time and improves these metabolic markers. Insulin levels will be measured using enzyme-linked immunosorbent assay (ElISA), reported in μU/mL.

  8 months

• Exercise timings and Metabolic health: Targeting C-peptide levels in Adults with Prediabetes post meal

  This study aims to investigate the effects of varied exercise timing post-meal (30 minutes, 60 min, 90 min, and 120 minutes) on C-peptide levels. C-peptide levels will be assessed at fasting, pre-exercise, and 30 and 60 minutes post exercise using an enzyme-linked immunosorbent assay (ELISA) and reported in ng/mL.

  8 months

• Exercise timings and Metabolic health: Targeting Lipid profile levels in Adults with Prediabetes post meal

  This study aims to investigate the effects of varied exercise timing post-meal (30 minutes, 60 min, 90 min, and 120 minutes) on Lipid profile. The lipid profile, including total cholesterol, LDL, HDL, and triglycerides, will be measured in mg/dL. Measurements will be taken at baseline and at each post-exercise interval. The outcome will determine the exercise timing that leads to the most favorable lipid profile changes.

  8 months

• Exercise timings and Metabolic health: Targeting MiRNA 192 expression levels in Adults with Prediabetes post meal

  This study aims to investigate the effects of varied exercise timing post-meal (30 minutes, 60 min, 90 min, and 120 minutes) on MiRNA-192. miRNA 192 expression levels will be measured using Real-time quantitative PCR (qPCR) techniques, with results presented as relative expression values. This outcome aims to identify which exercise timing most effectively influences miRNA 192 expression.

  8 months

• Exercise Intensities and Metabolic health: Targeting Blood glucose levels in Adults with Prediabetes post meal

  This study aims to investigate the effects of varied exercise intensities (50%,60%,70%, and 80%) on previously optimized meal intake time and commencement of exercise on blood glucose levels in a prediabetic population, to identify which intensity is that most effective and improves these metabolic markers. Blood glucose levels will be measured at baseline and at each post-exercise interval (30, 60, 90, and 120 minutes) in mg/dL, using a standard glucose meter.

  8 months

• Exercise Intensities and Metabolic health: Targeting Insulin levels in Adults with Prediabetes post meal

  This study aims to investigate the effects of varied exercise intensities (50%,60%,70%, and 80%) on previously optimized meal intake time and commencement of exercise on insulin levels in the prediabetic population, to identify which intensity is that most effective and improves these metabolic markers. Insulin levels will be measured at the same intervals using enzyme-linked immunosorbent assay Elisa, reported in μU/mL.

  8 months

• Exercise Intensities and Metabolic health: Targeting C-peptide levels in Adults with Prediabetes post meal

  This study aims to investigate the effects of varied exercise intensities (50%,60%,70%, and 80%) on previously optimized meal intake time and commencement of exercise on C-peptide levels in the prediabetic population, to identify which intensity is the most effective and improves these metabolic markers. It will be measured at the same intervals using enzyme-linked immunosorbent assay Elisa, reported in ng/mL.

  8 months

• Exercise Intensities and Metabolic health: Targeting Lipid Profile in Adults with Prediabetes post meal

  This study aims to investigate the effects of varied exercise intensities (50%,60%,70%, and 80%) on previously optimized meal intake time and commencement of exercise on Lipid profile. The lipid profile, including total cholesterol, LDL, HDL, and triglycerides, will be measured in mg/dL. Measurements will be taken at baseline and at each post-exercise interval. The outcome will determine the exercise timing that leads to the most favorable lipid profile changes.

  8 months

• Exercise Intensities and Metabolic health: Targeting MiRNA-192 in Adults with Prediabetes post meal

  This study aims to investigate the effects of varied exercise intensities (50%,60%,70%, and 80%) on previously optimized meal intake time and commencement of exercise on MiRNA-192. miRNA 192 expression levels will be measured using quantitative PCR (qPCR) techniques, with results presented as relative expression values. This outcome aims to identify which exercise timing most effectively influences miRNA 192 expression.

  8 months

• Exercise duration and Metabolic health: Targeting Blood glucose levels in Adults with Prediabetes post meal

  This study aims to investigate the effects of varied exercise duration of exercise (15, 30, 45, and 60 minutes workout) on previously optimized time and intensity on blood glucose levels. Blood glucose levels will be measured in mg/dL, using a standard glucose meter. The goal is to determine which exercise timing results in the most significant reduction in blood glucose levels.

  8 months

• Exercise duration and Metabolic health: Targeting Insulin levels in Adults with Prediabetes post meal

  This study aims to investigate the effects of varied exercise duration of exercise (15, 30, 45, and 60 minutes workout) on previously optimized time and intensity on insulin levels in a prediabetic population, to identify whichduration is the most effective and improves this metabolic marker. insulin levels will be measured at the same intervals using a chemiluminescence immunoassay, reported in μU/mL. This outcome aims to identify the optimal timing for exercise in reducing insulin levels.

  8 months

• Exercise duration and Metabolic health: Targeting C-peptide in Adults with Prediabetes post meal

  This study aims to investigate the effects of varied exercise duration of exercise (15, 30, 45, and 60 minutes workout) on previously optimized time and intensity on C-peptide levels in a prediabetic population, to identify which duration is the most effective and improves this metabolic marker. C-peptide levels will be assessed at each time point using an enzyme-linked immunosorbent assay (ELISA) and reported in ng/mL. The analysis will focus on the timing of exercise that maximizes reductions in C-peptide levels.

  8 months

• Exercise duration and Metabolic health: Targeting Lipid Profile in Adults with Prediabetes post meal

  This study aims to investigate the effects of varied exercise duration of exercise (15, 30, 45, and 60 minutes workout) on previously optimized time and intensity on Lipid Profile in a prediabetic population, to identify which duration is the most effective and improves thses metabolic marker. The lipid profile, including total cholesterol, LDL, HDL, and triglycerides, will be measured in mg/dL. Measurements will be taken at baseline and at each post-exercise interval. The outcome will determine the exercise timing that leads to the most favorable lipid profile changes.

  8 months

• Exercise duration and Metabolic health: Targeting MiRNA-192 in Adults with Prediabetes post meal

  This study aims to investigate the effects of varied exercise duration of exercise (15, 30, 45, and 60 minutes workout) on previously optimized time and intensity on MiRNA-192 in a prediabetic population, to identify which Duration is the most effective and improves the marker. miRNA 192 expression levels will be measured using quantitative PCR (qPCR) techniques, with results presented as relative expression values. This outcome aims to identify which exercise timing most effectively influences miRNA 192 expression.

  8 months

Study Arms (1)

optimizing exercise timing, intensity and duration with Prediabetes post meal

EXPERIMENTAL

The study is a sequential study design where a cohort of 25 will enter timing, intensity and duration protocols of exercise over 12 visits 7 days apart.

Behavioral: exercise intervention

Interventions

exercise intervention BEHAVIORAL

A total of 25 prediabetic adults of either gender will participate in the study they will engage in exercise at intensities of 50%, 60%, 70%, or 80% of their predicted maximum heart rate (PMHR). In duration they will exercise for 15, 30, 45 and 60 minutes, and in timing protocol they will exercise at various time points after having breakfast. Blood samples were collected at four time points i.e. at fasting, pre-exercise and post-exercise at 30 and 60 minutes to measure glucose, insulin, and C-peptide levels.

optimizing exercise timing, intensity and duration with Prediabetes post meal

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Prediabetic adults between 20-to-35-year age group with and without a family history of diabetes mellitus will be recruited into the study.
• Diagnosis of prediabetes will be made through HbA1c (prediabetic range is 5·7 - 6·4%), and impaired fasting glucose (fasting plasma glucose 5·6 -6·9 mmol/L) -

You may not qualify if:

• \. Participants with type 2 diabetes and other diseases, on lipid-lowering drugs, pregnant and lactating females or participating in some other study.

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead

Study Sites (1)

Khyber Medical University

Peshawar, Khyber Pukhtoon Khwa, 25000, Pakistan

Location

Related Publications (4)

• Rynders CA, Weltman JY, Jiang B, Breton M, Patrie J, Barrett EJ, Weltman A. Effects of exercise intensity on postprandial improvement in glucose disposal and insulin sensitivity in prediabetic adults. J Clin Endocrinol Metab. 2014 Jan;99(1):220-8. doi: 10.1210/jc.2013-2687. Epub 2013 Dec 20.

  PMID: 24243632 BACKGROUND

• Marliss EB, Vranic M. Intense exercise has unique effects on both insulin release and its roles in glucoregulation: implications for diabetes. Diabetes. 2002 Feb;51 Suppl 1:S271-83. doi: 10.2337/diabetes.51.2007.s271.

  PMID: 11815492 BACKGROUND

• Manders RJ, Van Dijk JW, van Loon LJ. Low-intensity exercise reduces the prevalence of hyperglycemia in type 2 diabetes. Med Sci Sports Exerc. 2010 Feb;42(2):219-25. doi: 10.1249/MSS.0b013e3181b3b16d.

  PMID: 19927038 BACKGROUND

• Irving BA, Davis CK, Brock DW, Weltman JY, Swift D, Barrett EJ, Gaesser GA, Weltman A. Effect of exercise training intensity on abdominal visceral fat and body composition. Med Sci Sports Exerc. 2008 Nov;40(11):1863-72. doi: 10.1249/MSS.0b013e3181801d40.

  PMID: 18845966 BACKGROUND

MeSH Terms

Conditions

Prediabetic State; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Saman Tauqir, Mphil

  Khyber Medical University Peshawar, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this interventional study, we will include prediabetic patients who will undergo three sequential exercise protocols to optimize exercise timing, intensity, and duration. Each protocol is designed to explore a unique combination of these exercise parameters, allowing us to assess the effects on health outcomes relevant to prediabetes management. By using a randomized, cross-over design, participants will experience different exercise regimens, enabling us to compare the impact of each combination on glucose control, cardiovascular health, and overall metabolic function. This study aims to develop evidence-based exercise guidelines specifically tailored to prediabetic individuals.

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 24, 2024
• Study Start: September 15, 2022
• Primary Completion: October 20, 2024
• Study Completion: November 20, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: January 2025 to March 2025
• Access Criteria: For this study, access to individual participant data (IPD) and supporting information will be controlled Who will access Primary Investigators: Members of the research team directly involved in data analysis and interpretation. Qualified Researchers: External researchers with relevant qualifications and interests in this field of study who meet the study's access criteria. Regulatory Bodies and Ethics Committees: Individuals from authorized regulatory agencies, ethics review boards, or other monitoring bodies, if required for compliance and oversight. What Data Will Be Accessible De-identified IPD: Anonymized individual participant data, including key variables related to the study outcomes and participant demographics. Supporting Documentation: This may include the study protocol, statistical analysis plan, informed consent forms, and data dictionaries. Summary Reports and Aggregated Results: Aggregated data or analysis summaries may be shared as part of broader research findings.

Locations

PA (1)