the Effect of Fasted Versus Post-meal HIIT on Glycemic Control in Men With Type 2 Diabetes Mellitus

NCT06659848 | Completed

• 2 other identifiers: SCBR-352/20242023/03/26426
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Recently, high intensity interval training (HIIT) has emerged as a promising regimen for the management of type 2 diabetic subjects. However, there is no consensus on the best time for HIIT regarding nutritional status. Purpose: to investigate the effect of fasted versus postprandial HIIT training on glycemic control in men with type 2 Diabetes Mellitus. Methods: This study enrolled 123 subjects suffering from type 2 diabetes mellitus with ages between 40 and 60 years. Subjects were divided into 4 groups, The post-breakfast, post-lunch and post-dinner groups practiced HIIT 2h after breakfast, lunch, and dinner respectively. The HIIT program involved 3 sessions weekly for 12 weeks. Glycated hemoglobin, fasting blood glucose, fasting insulin, insulin sensitivity, body composition, and blood lipid values were evaluated pre- and post-intervention.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Diabetes Mellitus; High Intensity Exercise; Glycemia

Outcome Measures

Primary Outcomes (1)

• Percentage of glycated hemoglobin

  Percentage of glycated hemoglobin (HbA1c) levels are measured using a Tosoh G7 automatic analyzer (Tosoh Bioscience, Tokyo, Japan).

  3 months

Secondary Outcomes (7)

• Body weight in kg

  3 months

• Body Mass Index (BMI) in kg/m2

  3 months

• Waist Circumference in cm

  3 months

• Concentration of Fasting plasma insulin in μU/ml

  3 months

• Concentration of Fasting blood glucose in mg/dl

  3 months

Study Arms (4)

Fasted-group

EXPERIMENTAL

practiced HIIT prebreakfast in the fasted state (8-12 h fasting)

Other: high intensity interval training

Post-breakfast

EXPERIMENTAL

practiced HIIT 2 hours after breakfast

Other: high intensity interval training

Post-lunch

EXPERIMENTAL

practiced HIIT 2 hours after lunch

Other: high intensity interval training

Post-dinner

EXPERIMENTAL

practiced HIIT 2 hours after dinner

Other: high intensity interval training

Interventions

high intensity interval training OTHER

The subjects in the four groups performed 12 weeks of supervised HIIE program on a motorized treadmill (h/p/cosmos, Pulsar 4.0, Nussdorf-Traunstein, Germany) with a rate of three sessions weekly. The session commenced with a 5 min warming-up and concluded with a 5 min cooling down period. The exercise effort component consisted of 5 intervals of HIIT. Each interval continues for four min of HIIT with exercise intensity ranging from 75% to 90% of the peak heart rate. Each active recovery period between exercise intervals included moderate exercise at intensity of 50% to 60% of the peak heart rate. Every 3 weeks, the exercise intensity was increased by 5% starting with 75% of the HRmax in the first 3 weeks, 80% in the following 3 weeks and progressed to 90% the HRmax in the last 3 weeks. The subject's heart rate throughout the HIIT session was monitored using a polar heart rate monitor (Polar, Kempele, Finland).

Fasted-group; Post-breakfast; Post-dinner; Post-lunch

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Only men diagnosed with T2DM,
• Aged 40-60 years
• Inactive (performing less than 150 min/week of moderate-intensity exercise for at least the last six months)

You may not qualify if:

• Subjects treated with exogenous insulin
• Cardiovascular diseases limiting participation in HIIT
• Musculoskeletal diseases limiting participation in HIIT

Sponsors & Collaborators

• Prince Sattam Bin Abdulaziz University: lead

Study Sites (1)

Prince Sattam bin Abdulaziz University

Al Kharj, Riyadh Region, 11942, Saudi Arabia

Location

Related Publications (12)

• Mancilla R, Brouwers B, Schrauwen-Hinderling VB, Hesselink MKC, Hoeks J, Schrauwen P. Exercise training elicits superior metabolic effects when performed in the afternoon compared to morning in metabolically compromised humans. Physiol Rep. 2021 Jan;8(24):e14669. doi: 10.14814/phy2.14669.

  PMID: 33356015 BACKGROUND

• Karstoft K, Winding K, Knudsen SH, Nielsen JS, Thomsen C, Pedersen BK, Solomon TP. The effects of free-living interval-walking training on glycemic control, body composition, and physical fitness in type 2 diabetic patients: a randomized, controlled trial. Diabetes Care. 2013 Feb;36(2):228-36. doi: 10.2337/dc12-0658. Epub 2012 Sep 21.

  PMID: 23002086 BACKGROUND

• Madsen SM, Thorup AC, Overgaard K, Jeppesen PB. High Intensity Interval Training Improves Glycaemic Control and Pancreatic beta Cell Function of Type 2 Diabetes Patients. PLoS One. 2015 Aug 10;10(8):e0133286. doi: 10.1371/journal.pone.0133286. eCollection 2015.

  PMID: 26258597 BACKGROUND

• Savikj M, Gabriel BM, Alm PS, Smith J, Caidahl K, Bjornholm M, Fritz T, Krook A, Zierath JR, Wallberg-Henriksson H. Afternoon exercise is more efficacious than morning exercise at improving blood glucose levels in individuals with type 2 diabetes: a randomised crossover trial. Diabetologia. 2019 Feb;62(2):233-237. doi: 10.1007/s00125-018-4767-z. Epub 2018 Nov 13.

  PMID: 30426166 BACKGROUND

• Verboven K, Wens I, Vandenabeele F, Stevens AN, Celie B, Lapauw B, Dendale P, VAN Loon LJC, Calders P, Hansen D. Impact of Exercise-Nutritional State Interactions in Patients with Type 2 Diabetes. Med Sci Sports Exerc. 2020 Mar;52(3):720-728. doi: 10.1249/MSS.0000000000002165.

  PMID: 31652237 BACKGROUND

• Nygaard H, Ronnestad BR, Hammarstrom D, Holmboe-Ottesen G, Hostmark AT. Effects of Exercise in the Fasted and Postprandial State on Interstitial Glucose in Hyperglycemic Individuals. J Sports Sci Med. 2017 Jun 1;16(2):254-263. eCollection 2017 Jun.

  PMID: 28630579 BACKGROUND

• Peddie MC, Bone JL, Rehrer NJ, Skeaff CM, Gray AR, Perry TL. Breaking prolonged sitting reduces postprandial glycemia in healthy, normal-weight adults: a randomized crossover trial. Am J Clin Nutr. 2013 Aug;98(2):358-66. doi: 10.3945/ajcn.112.051763. Epub 2013 Jun 26.

  PMID: 23803893 BACKGROUND

• Gillen JB, Little JP, Punthakee Z, Tarnopolsky MA, Riddell MC, Gibala MJ. Acute high-intensity interval exercise reduces the postprandial glucose response and prevalence of hyperglycaemia in patients with type 2 diabetes. Diabetes Obes Metab. 2012 Jun;14(6):575-7. doi: 10.1111/j.1463-1326.2012.01564.x. Epub 2012 Feb 20.

  PMID: 22268455 BACKGROUND

• Hamasaki H. Daily physical activity and type 2 diabetes: A review. World J Diabetes. 2016 Jun 25;7(12):243-51. doi: 10.4239/wjd.v7.i12.243.

  PMID: 27350847 BACKGROUND

• Kanaley JA, Colberg SR, Corcoran MH, Malin SK, Rodriguez NR, Crespo CJ, Kirwan JP, Zierath JR. Exercise/Physical Activity in Individuals with Type 2 Diabetes: A Consensus Statement from the American College of Sports Medicine. Med Sci Sports Exerc. 2022 Feb 1;54(2):353-368. doi: 10.1249/MSS.0000000000002800.

  PMID: 35029593 BACKGROUND

• American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S15-S33. doi: 10.2337/dc21-S002.

  PMID: 33298413 BACKGROUND

• Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.

  PMID: 31518657 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ahmed S Ahmed, PhD

  1Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A total of 160 men with T2DM were recruited from nearby hospitals and clinics to participate in this study and 123 completed the study follow-up. A licensed physician performed the preliminary evaluation for all participants. Participants were instructed to maintain their medications, their usual dietary habits and usual physical activity throughout the study period. Only men diagnosed with T2DM, aged 40-60 years and inactive (performing less than 150 min/week of moderate-intensity exercise for at least the last six months) were included in this study. Subjects treated with exogenous insulin, and those with cardiovascular or musculoskeletal diseases limiting participation in HIIT were excluded. Eligible subjects were randomly assigned to one of four groups. The Fasted-group practiced HIIT prebreakfast in the fasted state (8-12 h fasting). The Post-breakfast, Post-lunch and Post-dinner groups practiced HIIT 2h after breakfast, lunch, and dinner respectively. The primary outcome was gly

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 26, 2024
• Study Start: June 20, 2024
• Primary Completion: August 30, 2024
• Study Completion: October 20, 2024
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)