Forearm Immobilization in T2D

Not Applicable

Recruiting

• Conditions: Healthy; Type 2 Diabetes

• Registration Number: NCT06750497
• Lead Sponsor: Wageningen University

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.

Study Timeline

• Study Start: 2024-11-21
• Study First Submitted: 2024-11-22
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in forearm muscle glucose uptake	From 0 to 48 hours	The change in postprandial muscle insulin sensitivity, measured as forearm glucose uptake, from pre-immobilization to post-immobilization

Secondary Outcome Measures

Name	Time	Method
Temporal change in forearm glucose uptake	Prior to and for 3.5 hours following each meal consumption	The change in postprandial muscle insulin sensitivity, measured as the temporal response of forearm glucose uptake (FGU), in response to repeated meals during 48h of forearm immobilization
Change in forearm muscle amino acid kinetics	Baseline and at regular intervals for 3.5 hours following the first and last meal consumption during the test period (0 to 48 hours)	Plasma phenylalanine kinetics assessed using a stable isotope tracer infusion. Measurements include the rate of appearance (Ra), rate of disappearance (Rd), and net balance (NB) of phenylalanine across the forearm.
Change in whole-body substrate oxidation	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.	Change in whole-body substrate oxidation measured using indirect calorimetry, measured before and in response to repeated mixed meals

Trial Locations

Locations (1)

Wageningen University and Research; 🇳🇱 Wageningen, Gelderland, Netherlands