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RecruitingNCT06750497FIT2DUpdated Jul 2, 2026

Forearm Immobilization in T2D

An interventional study of Forearm immobilization in Healthy and Type 2 Diabetes, sponsored by Wageningen University. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by Wageningen University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy
  • Type 2 Diabetes
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (estimated)

Study arms

  • Experimental
    Participants with Type 2 Diabetes

    Two days of standardized meal consumption

    Behavioral: Forearm immobilization

  • Experimental
    Participants without Type 2 Diabetes

    Two days of standardized meal consumption

    Behavioral: Forearm immobilization

Interventions

  • BehavioralForearm immobilization

    Two days of forearm immobilization

05

What researchers measure

Primary outcomes

  1. Change in forearm muscle glucose uptake

    The change in postprandial muscle insulin sensitivity, measured as forearm glucose uptake, from pre-immobilization to post-immobilization

    Time frame: From 0 to 48 hours

Secondary outcomes

  1. 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

    Time frame: Prior to and for 3.5 hours following every meal consumption during the 48 hours forearm immobilization period

  2. 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.

    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)

  3. 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.

    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)

  4. 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.

    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)

  5. 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

    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.

06

Study locations

1 of 1 sites recruiting
  • Wageningen University and Research
    Wageningen, Gelderland 6708WD, Netherlands
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06750497
Lead sponsor
Wageningen University
Responsible party
Marlou Dirks (Assistant Professor, Wageningen University) — Principal investigator
First posted
Dec 27, 2024
Start date
Nov 21, 2024
Primary completion
Apr 30, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Jul 2, 2026

Study contacts

Marlou Dirks, PhD
Contact
marlou.dirks@wur.nl
+31 317 480 100

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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