Health TrialsbyHealthPanel

Forearm Immobilization in T2D

ConditionsHealthyType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWageningen University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Forearm immobilization

    Behavioral

    Two days of forearm immobilization

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: Participants with Type 2 DiabetesExperimental treatment 1 intervention
Group B: Participants without Type 2 DiabetesExperimental treatment 1 intervention

Trial outcomes

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wageningen University

Lead sponsor

Source ClinicalTrials.gov
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