Type 1 DiabetesSARCO_DM1NCT06902597
Association Between Sarcopenia And Diabetic Neuropathy In Adults With Type 1 Diabetes, A Pilot Study
A study testing Dual energy X-ray absorptiometry in people with Type 1 Diabetes, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Monocentric interventional prospective study to evaluate the prevalence of sarcopenia in adults with type 1 diabetes (T1DM) and to evaluate the association between diabetic neuropathy and sarcopenia in subjects with T1DM; to evaluate the prevalence of dynapenia in adults with T1DM and its association with diabetic… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Dual energy X-ray absorptiometry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2025to 31 Jan 2026
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50-80 years, both sexes
- Diagnosis of T1DM for at least 10 years, in both multiple daily injections of insulin (MDI) and continuous subcutaneous insulin infusion (CSII)
- Informed consent before any study activity
- Ability to fully perform all protocol activities
Who cannot join
- Previous diagnosis of T2DM
- Previous diagnosis of dementia
- Presence of heart failure (NYHA class III and IV)
- Presence of muscular disease
- Diagnosis of neurodegenerative disease (e.g. multiple sclerosis, Parkinson's disease)
- eGFR evaluated through CKD-EPI formula <20 ml/min /1.73m2 , estimated on previous creatinine dosage
Show all 18Show fewer
- Previous history of stroke or cerebrovascular disease
- Diagnosis of coeliac disease
- Diagnosis of chronic inflammatory bowel disease
- Untreated hypothyroidism or hyperthyroidism or not well controlled hypothyroidism or hyperthyroidism with current therapy (TSH >5 or TSH <0.15)
- Alcohol abuse or consumption of more than 14 alcoholic units weekly
- Active cancer or therapy
- Pregnancy
- Primary hyperparathyroidism
- Corticosteroid and/or estrogen-progestogen therapy for at least 12 months in medical history
- On going treatment with antiretroviral therapy
- On going treatment with immunosuppressive therapy, e.g. cyclosporine, tacrolimus
- On going treatment with anti-epileptic drugs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS; UOC Diabetologia
Rome, Lazio, 00168
Dario Pitocco, Prof, +390630155701, dario.pitocco@policlinicogemelli.it
Dario Pitocco
About this study
Monocentric interventional prospective study to evaluate the prevalence of sarcopenia in adults with type 1 diabetes (T1DM) and to evaluate the association between diabetic neuropathy and sarcopenia in subjects with T1DM; to evaluate the prevalence of dynapenia in adults with T1DM and its association with diabetic neuropathy.
- Conditions
- Type 1 Diabetes
- Being tested
- Dual energy X-ray absorptiometry
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual energy X-ray absorptiometryProcedure or surgery
Also called DEXA (Dual X-ray Absorptiometry)
Very low radiation dose technique to show fat mass (FM) and lean mass (LM)
| Study group | Role | What they receive |
|---|---|---|
| Type 1 Diabetes | Experimental | Subjects with type 1 diabetes who will be evaluated for sarcopenia, evaluating body composition through DEXA and muscular strength by handgrip. Receives: Procedure: Dual energy X-ray absorptiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of sarcopenia
Prevalence of sarcopenia in adult population with T1DM. Sarcopenia will be defined according to the 2018 European Working Group on Sarcopenia in Older People (EWGSOP) guidelines
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Prevalence of microvascular complications in subjects with T1DM and sarcopenia
Prevalence of peripheral diabetic neuropathy, autonomic diabetic neuropathy, diabetic retinopathy, diabetic nephropathy in subjects with T1DM and sarcopenia
Measured: through study completion, an average of 1 year
Prevalence of dynapenia
Prevalence of dynapenia
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 Feb 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dario Pitocco, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902597
- Sponsor's protocol ID
- 7119
- Acronym
- SARCO_DM1
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2025
- Last updated
- 30 Mar 2025
- 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 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Sarcopenia And Diabetic Neuropathy In Adults With Type 1 Diabetes, A Pilot Study
- ClinicalTrials.gov ID
- NCT06902597
- Acronym / sponsor ID
- SARCO_DM1 / 7119
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 30 Mar 2025 (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.
Monocentric interventional prospective study to evaluate the prevalence of sarcopenia in adults with type 1 diabetes (T1DM) and to evaluate the association between diabetic neuropathy and sarcopenia in subjects with T1DM; to evaluate the prevalence of dynapenia in adults with T1DM and its association with diabetic neuropathy.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 1 Diabetes | Experimental | Procedure: Dual energy X-ray absorptiometrySubjects with type 1 diabetes who will be evaluated for sarcopenia, evaluating body composition through DEXA and muscular strength by handgrip. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 50-80 years, both sexes
- Diagnosis of T1DM for at least 10 years, in both multiple daily injections of insulin (MDI) and continuous subcutaneous insulin infusion (CSII)
- Informed consent before any study activity
- Ability to fully perform all protocol activities
Key exclusion criteria (18 listed)
- Previous diagnosis of T2DM
- Previous diagnosis of dementia
- Presence of heart failure (NYHA class III and IV)
- Presence of muscular disease
- Diagnosis of neurodegenerative disease (e.g. multiple sclerosis, Parkinson's disease)
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 |
|---|---|---|
| Dual energy X-ray absorptiometryAlso: DEXA (Dual X-ray Absorptiometry)Very low radiation dose technique to show fat mass (FM) and lean mass (LM) | Procedure or surgery | Type 1 Diabetes |
Primary outcome
Prevalence of sarcopenia
Time frame: through study completion, an average of 1 year
Prevalence of sarcopenia in adult population with T1DM. Sarcopenia will be defined according to the 2018 European Working Group on Sarcopenia in Older People (EWGSOP) guidelines
2 secondary outcomes
Prevalence of microvascular complications in subjects with T1DM and sarcopenia
Time frame: through study completion, an average of 1 year
Prevalence of dynapenia
Time frame: through study completion, an average of 1 year
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 30 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Dario Pitocco principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual energy X-ray absorptiometry in people with Type 1 Diabetes, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 18 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 30 Mar 2025. 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 Italy. 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 Dario Pitocco (+39 0630154071, dario.pitocco@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of sarcopenia (time frame: through study completion, an average of 1 year). 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 30 Mar 2025.