Forearm Immobilization in T2D (FIT2D)

Wageningen University

Status: Enrolling

Conditions: Healthy; Type 2 Diabetes

Treatments: Behavioral: Forearm immobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT06750497

NL87404.028.24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Participants with Type 2 Diabetes

Experimental group

Description:

Two days of standardized meal consumption

Treatment:

Behavioral: Forearm immobilization

Participants without Type 2 Diabetes

Experimental group

Description:

Two days of standardized meal consumption

Treatment:

Behavioral: Forearm immobilization