Logo 1 Logo 2

Clinical Trial Details

Trial ID: L6839
Source ID: NCT05606471
Associated Drug: Semaglutide Pen Injector [Ozempic]
Title: Glucagon-like Peptide-1 Agonism With Very Low Calorie Diets
Acronym: SemVLCD
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus in Obese
Interventions: DRUG: Semaglutide Pen Injector [Ozempic]|DIETARY_SUPPLEMENT: Very-low Calorie Diet
Outcome Measures: Primary: Muscle protein synthesis rate, Measuring the rate of skeletal muscle growth in vivo by determining the rate of deuterium incorporation into muscle, 6 weeks|Muscle protein breakdown rate, Measuring the rate of breakdown of skeletal muscle in vivo using the rate of appearance of deuterium-labelled 3-methyl-histidine in blood after an initial oral bolus, 6 weeks | Secondary: Skeletal muscle mass, Determined from DXA scanning (measured in kg and percentage of total body weight) and novel techniques using rate of appearance of a creatine tracer in urine after an initial bolus, 12 weeks|Fat mass, Determined from DXA scanning (measured in kg and percentage of total body weight), 12 weeks|Total body weight, Measured in kg, 12 weeks|Whole body insulin sensitivity, Determined using the intravenous glucose tolerance test and measures of fasting insulin \& glucose, 12 weeks|Pancreatic beta cell function, Determined using the intravenous glucose tolerance test and measures of fasting insulin \& glucose, 12 weeks|Skeletal muscle strength, Determined from maximal voluntary contraction (MVC) of left knee extension, 12 weeks|Skeletal neuromuscular function, Assessed using measurement of force stability during electromyography, 12 weeks|Gross skeletal muscle function, Measured using a short battery of physical performance tests (SBPPT) to give an overall score of skeletal gross skeletal muscle function (scored out of 12), 12 weeks|Right vastus lateralis muscle thickness, Determined from muscle ultrasonography, 12 weeks|Right vastus lateralis muscle cross sectional area (CSA), Determined from muscle ultrasonography, 12 weeks|Right vastus lateralis muscle fibre pennation angle, Determined from muscle ultrasonography, 12 weeks
Sponsor/Collaborators: Sponsor: University of Nottingham | Collaborators: Medical Research Council
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 45
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-09-15
Completion Date: 2023-07-28
Results First Posted:
Last Update Posted: 2022-11-04
Locations: University of Nottingham, Royal Derby Hospital Centre, Derby, DE22 3DT, United Kingdom
URL: https://clinicaltrials.gov/show/NCT05606471