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Clinical Trial Details

Trial ID: L4944
Source ID: NCT03316690
Associated Drug: Metformin Treatment
Title: The Interaction Between Metformin and Physical Training
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Impaired Glucose Tolerance|Diabetes Mellitus, Type 2
Interventions: DRUG: Metformin treatment|DRUG: Placebo treatment|BEHAVIORAL: Physical training
Outcome Measures: Primary: Change in postprandial glycemic control as assessed by mean blood glucose concentration during a 4 hour mixed-meal tolerance test, Day 0 (before randomisation), 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training) | Secondary: Change in free-living glycemic control, Blood HbA1c levels, Day 0 (before randomisation), 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)|Change in endogenous glucose production as assessed by rate of infused glucose tracer appearance in blood, Day 0 (before randomisation), 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)|Change in exogenous glucose uptake as assessed by rate of ingested glucose tracer appearance in blood, Day 0 (before randomisation), 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)|Change in peripheral glucose uptake as assessed by rate of glucose disappearance from blood, Day 0 (before randomisation), 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)|Change in maximal oxygen consumption, Maximal oxygen uptake during an incremental bicycle test, Day 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)|Change in body weight, Body weight measured by standard procedures, Day 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)|Change in lean body mass, Lean body mass evaluated via Dual energy x-ray absorptiometry (Dxa), Day 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)|Change in total fat mass, Total body fat mass evaluated via Dual energy x-ray absorptiometry (Dxa), Day 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)|Change in visceral fat mass, Visceral fat mass evaluated via magnetic resonance imaging (MRI) scans, Day 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)|Change in AMPK activity in skeletal muscle, AMPK activity measured via western blotting and activity assays, Day 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)|Change in skeletal muscle oxidative stress, Muscle mitochondrial oxidative stress measured via respirometry in muscle biopsies, Day 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)|Change in systemic oxidative stress, Systemic oxidative stress measured via RNA/DNA oxidation products in urine, Day 0 (before randomisation), 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)|Maximal mitochondrial respiration, Maximal mitochondrial respiration measured via respirometry in muscle biopsies, Day 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)|Training heart rate, Heart rate will be measured continuously during all training sessions, Average heart rate during all training sessions (through study completion, [Day 101])|Training rate of perceived exertion, Rate of perceived exertion measured via a Borg scale (range 6-20 where higher values indicate higher rate of perceived exertion) will be assessed for each training session, Average rate of perceived exertion of all training sessions (through study completion, [Day 101])
Sponsor/Collaborators: Sponsor: Kristian Karstoft | Collaborators: University of Copenhagen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 34
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2017-10-20
Completion Date: 2018-10-01
Results First Posted:
Last Update Posted: 2018-11-09
Locations: Center for aktiv sundhed, Copenhagen, Copenhagen N, 2200, Denmark
URL: https://clinicaltrials.gov/show/NCT03316690