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Recruiting NCT06750497

Forearm Immobilization in T2D

No phase Interventional Healthy Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Forearm immobilization.
Who it may be relevant to
Registry conditions: Healthy, Type 2 Diabetes. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Behavioral Forearm immobilization
    Two days of forearm immobilization

Primary outcome measures

  • Change in forearm muscle glucose uptake [Time frame: From 0 to 48 hours]
Secondary outcome measures (5)
  • 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]
  • 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)]
  • 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)]
  • 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)]
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

Netherlands · 1 center
  • Wageningen University and Research — Wageningen

Identifiers

NCT: NCT06750497 · NL87404.028.24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗