Forearm Immobilization in T2D

NCT06750497 | Recruiting

• 1 other identifier: NL87404.028.24
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy; Type 2 Diabetes

Outcome Measures

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

  From 0 to 48 hours

Secondary Outcomes (5)

• Temporal change in forearm glucose uptake

  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

  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

  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

  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

  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.

Study Arms (2)

Participants with Type 2 Diabetes

EXPERIMENTAL

Two days of standardized meal consumption

Behavioral: Forearm immobilization

Participants without Type 2 Diabetes

EXPERIMENTAL

Two days of standardized meal consumption

Behavioral: Forearm immobilization

Interventions

Forearm immobilization BEHAVIORAL

Two days of forearm immobilization

Participants with Type 2 Diabetes; Participants without Type 2 Diabetes

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ≥ BMI ≤ 35 kg·m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University: lead

Study Sites (1)

Wageningen University and Research

Wageningen, Gelderland, 6708WD, Netherlands

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Marlou Dirks, PhD

CONTACT

+31 317 480 100; marlou.dirks@wur.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 27, 2024
• Study Start: November 21, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)