HealthyFIT2DNCT06750497
Forearm Immobilization in T2D
A study testing Forearm immobilization in people with Healthy and Type 2 Diabetes, run by Wageningen University at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Type 2 Diabetes
- What is being tested?
- Forearm immobilization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Nov 2024to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Wageningen University and Research
Wageningen, Gelderland, 6708WD
Human and Animal Physiology, +31 (0)317 484 136, office.hap@wur.nl
About this study
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
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.
Read the 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.
- Conditions
- Healthy, Type 2 Diabetes
- Being tested
- Forearm immobilization
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forearm immobilizationBehavioural
Two days of forearm immobilization
| Study group | Role | What they receive |
|---|---|---|
| Participants with Type 2 Diabetes | Experimental | Two days of standardized meal consumption Receives: Behavioral: Forearm immobilization |
| Participants without Type 2 Diabetes | Experimental | Two days of standardized meal consumption Receives: Behavioral: Forearm immobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in forearm muscle glucose uptake
The change in postprandial muscle insulin sensitivity, measured as forearm glucose uptake, from pre-immobilization to post-immobilization
Measured: From 0 to 48 hours
Secondary outcomes (5)
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
Measured: 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
Plasma phenylalanine kinetics assessed using a stable isotope tracer infusion. Measurements include the rate of appearance (Ra) of phenylalanine across the forearm.
Measured: 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
Plasma phenylalanine kinetics assessed using a stable isotope tracer infusion. Measurements include the rate of disappearance (Rd) of phenylalanine across the forearm.
Measured: 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
Plasma phenylalanine kinetics assessed using a stable isotope tracer infusion. Measurements include the net balance (NB) of phenylalanine across the forearm.
Measured: 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
Change in whole-body substrate oxidation measured using indirect calorimetry, measured before and in response to repeated mixed meals
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start21 Nov 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlou Dirks, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750497
- Sponsor's protocol ID
- NL87404.028.24
- Acronym
- FIT2D
- Status last verified
- Jul 2026
- First submitted
- 22 Nov 2024
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06750497
- Acronym / sponsor ID
- FIT2D / NL87404.028.24
- Conditions
- Healthy, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Type 2 Diabetes | Experimental | Behavioral: Forearm immobilizationTwo days of standardized meal consumption |
| Participants without Type 2 Diabetes | Experimental | Behavioral: Forearm immobilizationTwo days of standardized meal consumption |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forearm immobilizationTwo days of forearm immobilization | Behavioural | Participants with Type 2 Diabetes, Participants without Type 2 Diabetes |
Primary outcome
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
5 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forearm immobilization in people with Healthy and Type 2 Diabetes, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marlou Dirks, PhD (+31 317 480 100, marlou.dirks@wur.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in forearm muscle glucose uptake (time frame: From 0 to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.