Forearm Immobilization in T2D (FIT2D)

The Impact of Short-term Forearm Immobilization on Forearm Muscle Glucose and Amino Acid Metabolism of Volunteers With or Without Type 2 Diabetes

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Type 2 Diabetes
• Intervention / Treatment: Behavioral: Forearm immobilization

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 Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marlou Dirks, PhD; Phone Number: +31 317 480 100; Email: marlou.dirks@wur.nl

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6708WD
      • Recruiting
      • Wageningen University and Research
      • Contact: Human and Animal Physiology; Phone Number: +31 (0)317 484 136; Email: office.hap@wur.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria

• Males and females with or without diagnosed type 2 diabetes
• Use lifestyle changes, metformin, gliclazide, or a combination thereof as oral glucose-lowering treatments for T2D
• Aged 18-80 years at the time of signing informed consent
• 18.5 ≥ BMI ≤ 35 kg·m2

Exclusion criteria

• Type 1 or a genetic form of diabetes
• Any diagnosed cardiovascular (heart) disease or high blood pressure (≥160 mmHg systolic and/or ≥100 mmHg diastolic)
• Chronic use of any prescribed or over-the-counter pharmaceuticals (excluding oral contraceptives and contraceptive devices) that interact with muscle substrate metabolism (e.g. selective serotonin reuptake inhibitors)
• Consumption of 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)
• Any previous motor disorders or inborn errors 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
• Claustrophobia
• Unable to give consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants with Type 2 Diabetes; Two days of standardized meal consumption	Behavioral: Forearm immobilization; Two days of forearm immobilization
Experimental: Participants without Type 2 Diabetes; Two days of standardized meal consumption	Behavioral: Forearm immobilization; Two days of forearm immobilization

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wageningen University

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2024
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NL87404.028.24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No