Clinical trial NCT06750497: Forearm Immobilization in T2D
Official title: The Impact of Short-term Forearm Immobilization on Forearm Muscle Glucose and Amino Acid Metabolism of Volunteers with or Without Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Type 2 Diabetes
Lead sponsor: Wageningen University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the present study is to assess the impact of short-term forearm immobilization on forearm muscle glucose uptake and amino acid net balance and kinetics in individuals with T2D compared with a control group with normoglycaemia.

Detailed description: Participants with and without T2D will undergo 2 days of forearm immobilization as a model of local physical inactivity. Before, throughout, and after immobilization arteriovenous forearm balance measurements will be combined with a stable isotope tracer infusion to measure muscle glucose uptake and amino acid balance, uptake, and efflux.

Eligibility criteria: Inclusion Criteria:

* Males and females with or without diagnosed type 2 diabetes (diagnosed at least one year prior)
* Apply lifestyle changes and/or use metformin as oral glucose-lowering medication as treatment for T2D
* Aged 18-65 years at the time of signing informed consent
* 18.5 \< BMI \< 30 kg·m2

Exclusion Criteria:

Type 1 or a genetic form of diabetes

* Any diagnosed cardiovascular (heart) disease or high blood pressure (≥140 mmHg systolic and/or

  ≥90 mmHg diastolic)
* Chronic use of any prescribed or over-the-counter pharmaceuticals (excluding oral contraceptives and contraceptive devices)
* Do not consume three regular meals a day (breakfast, lunch, and dinner) and or follows a low carbohydrate diet
* Smoking or chewing tobacco
* Known anaemia
* Regular use of dietary protein and/or amino acid supplements (\>3 times per week)
* Currently involved in a structured progressive resistance training program (\>3 times per week)
* A personal or family history of thrombosis (clots), epilepsy, seizures, or schizophrenia
* Any previous motor disorders or disorders in muscle and/or lipid metabolism
* History of kidney disease
* History of liver disease
* Pregnant or breastfeeding
* History of any drug or alcohol abuse in the past two years
* Any musculoskeletal injury of the arms in the 12 months before starting the study
* Claustrophobia
* Unable to give consent

Primary outcomes:
measure: Change in forearm muscle glucose uptake
timeFrame: From 0 to 48 hours
Secondary outcomes:
measure: Temporal change in forearm glucose uptake
timeFrame: Prior to and for 3.5 hours following each meal consumption
measure: Change in forearm muscle amino acid kinetics
timeFrame: Baseline and at regular intervals for 3.5 hours following the first and last meal consumption during the test period (0 to 48 hours)
measure: Change in whole-body substrate oxidation
timeFrame: Measurements will be performed at baseline, and at postprandial intervals (at 1 hour, 2 hours, 3 hours) during a 0 to 48-hour test period.
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University and Research
state: Gelderland
Study officials:
References: