Exercise, Gut Microbiota and Type 2 Diabetes
NCT Number: NCT06562842
Acronym: Ex-GM-T2D
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 2 Diabetes
Interventions: OTHER: Regular exercise|OTHER: Control comparator
Sponsor: University of Thessaly
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-09-01
Completion Date: 2025-10-30
Locations: Department of Physical Education and Sport Science, Uninersity of Thessaly, Tríkala, 42100, Greece

Summary:
This randomized, parallel, controlled study, will investigate the effect of regular exercise on GM composition, inflammatory status, and insulin sensitivity, in the progression from normal glucose tolerance (NGT), to prediabetes (pre-D), to type 2 diabetes (T2D). Following baseline assessment of glucose tolerance, the participants will be randomly assigned to either a 12-week, thrice-weekly exercise training program followed by 4 weeks of detraining, or will remain sedentary for the 16-week intervention. Thus, the six study groups will be: 1) NGT group (NGT), NGT individuals - no exercise, 2) NGT exercise group (NGT+Ex), NGT individuals that will participate in training and detraining, 3) pre-D group (pre-D), pre-D individuals - no exercise, 4) pre-D exercise group (Pre-D+Ex), pre-D individuals that will participate in training and detraining, 5) T2D group (T2D), T2D individuals - no exercise, and 6) T2D exercise group (T2D+Ex), T2D individuals that will participate in training and detraining. Assessment of physiological measures, anthropometric characteristics, body composition, glucose tolerance, insulin sensitivity, complete blood count, lipidemic profile, GM composition, inflammatory status, oxidative stress, and muscle performance, will be conducted before and following 12 weeks of the exercise training intervention and following 4 weeks of detraining for all participants.

Primary Outcome Measures: Changes in gut microbiota composition, Gut microbiota composition will be assessed in feces via Next generation sequencing, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in butyrate, Butyrate will be assessed in feces via HPLC/MS, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in propionate, Propionate will be assessed in feces via HPLC/MS, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in acetate, Acetate will be assessed in feces via HPLC/MS, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in White blood cells (WBC), WBC will be assessed in whole blood via hematological analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in Lymphocytes (LYM), LYM will be assessed in whole blood via hematological analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in Monocytes (MON), MON will be assessed in whole blood via hematological analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in Granulocytes (GRA), GRA will be assessed in whole blood via hematological analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in percent Lymphocytes (LYM%), LYM% will be assessed in whole blood via hematological analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in percent Monocytes (MON%), MON% will be assessed in whole blood via hematological analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in percent Granulocytes (GRA%), GRA% will be assessed in whole blood via hematological analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in Red blood cells (RBC), RBC will be assessed in whole blood via hematological analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in Hemoglobin (HGB), HGB will be assessed in whole blood via hematological analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in Hematocrit (HCT), HCT will be assessed in whole blood via hematological analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in Mean corpuscular volume (MCV), MCV will be assessed in whole blood via hematological analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in Mean corpuscular hemoglobin (MCH), MCH will be assessed in whole blood via hematological analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in Mean corpuscular hemoglobin concentration (MCHC), MCHC will be assessed in whole blood via hematological analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in Red cell distribution width (RDW), RDW will be assessed in whole blood via hematological analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in Platelets (PLT), PLT will be assessed in whole blood via hematological analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in Mean platelets volume (MPV), MPV will be assessed in whole blood via hematological analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in Plateletcrit (PCT), PCT will be assessed in whole blood via hematological analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in Plateletcrit distribution width (PDW), PDW will be assessed in whole blood via hematological analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in TNF-α concentration, TNF-α concentration will be assessed in serum via ELISA, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in IL-6 concentration, IL-6 concentration will be assessed in serum via ELISA, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in high-sensitivity C-reactive protein concentration, C-reactive protein concentration will be assessed in serum via ELISA, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in lipopolysacharides-binding protein (LBP) concentration, LBP concentration will be assessed in serum via ELISA, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in zonulin concentration, Zonulin concentration will be assessed in serum and in feces via ELISA, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in protein carbonyls (PC) concentration, PC concentration will be assessed in plasma via a spectrophotometer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in malondialdehyde (MDA) concentration, MDA concentration will be assessed in plasma via HPLC, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in reduced glutathione (GSH) concentration, GSH concentration will be assessed in red blood cells lycate via a spectrophotometer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in oxidized glutathione (GSSG) concentration, GSSG concentration will be assessed in red blood cells lycate via a spectrophotometer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in GSH/GSSG ratio, GSH/GSSG ratio will be calculated by dividing GSH concentration with GSSG concentration, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in catalase concentration, Catalase concentration will be assessed in red blood cells lycate via a spectrophotometer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in total antioxidant capacity (TAC), TAC will be assessed in red blood cells lycate via a spectrophotometer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in uric acid concentration, Uric acid concentration will be assessed in serum via a biochemical analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in bilirubin concentration, Bilirubin concentration will be assessed in serum via a biochemical analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in glycosylated hemoblobin (HbA1c) concentration, HbA1c concentration will be assessed in whole blood via a HbA1c analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in fasting plasma glucose, Fasting plasma glucose will be assessed in plasma via a biochemical analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in fasting plasma insulin, Fasting plasma insulin will be assessed in plasma via a biochemical analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in insulin resistance, Insulin resistance will be calulated via the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in insulin resistance - Oral glucose tolerance test (OGTT), OGTT will be assessed via the estimation of 2-h plasma glucose following oral glucose consumption, Pre, 30 minutes post-, 60 minutes post-, 90 minutes post-,120 minutes post-glucose consumption|Changes in total cholesterol (CHOL-T), CHOL-T will be assessed via a biochemical analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in low-density lipoprotein cholesterol (LDL-C), LDL-C will be assessed via a biochemical analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in high-density lipoprotein cholesterol (HDL-C), HDL-C will be assessed via a biochemical analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in triglycerides (TG), TG will be assessed via a biochemical analyzer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in countermovement jump height (CMJ), CMJ height will be measured via an optical system, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in isokinetic strength of knee extensors and knee flexors, Isometric, concentric and eccentric peak torque of the knee extensors and knee flexors of both limbs will be assessed via an isokinetic dynamometer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in handgrip strength, Handgrip strength will be assessed via a handgrip dynamometer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in resting heart rate (HR), Resting HR will be assessed via a HR monitor, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in resting systolic (SBP) and diastolic blood pressure (DBP), Resting SBP and DBP will be assessed via a manual sphygmomanometer, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in resting metabolic rate (RMR), RMR will be assessed via indirect calorimetry, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in body mass (BM), BM will be assessed via a stadiometer-Beam balance, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in body height, Body height will be assessed via a stadiometer-Beam balance, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in body mass index (BMI), BMI will be calculated by dividing body mass by the square of body height, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)|Changes in maximal oxygen uptake (VO2max), Changes in maximal oxygen uptake (VO2peak) will be assesed via a submaximal test on a treadmill, Baseline (pre), 12 weeks post-training, 16 weeks (post-detraining)