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NCT Number: NCT06750497

Forearm Immobilization in T2D

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.

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Key information

Conditions

Healthy Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University and Research

Wageningen, Gelderland, 6708WD, Netherlands

Location status: Recruiting

Location contact

Human and Animal Physiology

CONTACT

[email protected]

+31 (0)317 484 136

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Forearm immobilization

Behavioral

Two days of forearm immobilization

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Marlou Dirks, PhD

CONTACT

[email protected]

+31 317 480 100

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Registry information

Official study title

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

Acronym: FIT2D

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 27, 2024
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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