Forearm Immobilization in T2D (FIT2D)

July 1, 2026 updated by: Marlou Dirks, Wageningen University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: From 0 to 48 hours
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
Time Frame: 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
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
Time Frame: Prior to and for 3.5 hours following every meal consumption during the 48 hours forearm immobilization period
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
Time Frame: 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) 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
Time Frame: 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 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
Time Frame: 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 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

This is where you will find people and organizations involved with this study.

Sponsor

Wageningen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2024

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

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 2, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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