Diabetes Mellitus, Type 2NCT04484883
Performance of Six Equations for Estimating Resting Energy Expenditure in Patients With Type 2 Diabetes
An observational study of Diabetes Mellitus, Type 2, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
Trial summary
The present study evaluated the statistical and clinical performance of the six common equations in subjects with type 2 diabetes adopting indirect calorimetry as reference standard Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Observational
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Child, Adult, Older adult
Study population: 250 patients (124 females and 126 males, mean age 61.9 ± 8.5 years)
Who may be able to join
- Patients with type 2 diabetes
- Available resting energy expenditure assessed by indirect calorimetry
Who cannot join
- data on ongoing therapy (e.g. lifestyle measures with or without approved drugs), anthropometric or laboratory parameters (including white blood count, estimated glomerular filtration rate, TSH), or REE assessed by the means of indirect calorimetry could not be retrieved
- presenting with conditions known to affect indirect calorimetry (e.g. patients with strenuous exercise on the day before, asymptomatic patients with severe chronic kidney disease (eGFR < 30 ml/min/ 1.73 m2), increased white blood count, or subnormal TSH)
Trial locations and contacts
1 site in 1 country.
Italy1 site
National Institute of Gastroenterology IRCCS S. de Bellis
Castellana Grotte, Bari, 70013
About this study
The present study evaluated the statistical and clinical performance of the six common equations in subjects with type 2 diabetes adopting indirect calorimetry as reference standard
Read the detailed description
All consecutive subjects with type 2 diabetes referred from June 2012 to December 2019 were eligible. They were excluded if data on ongoing therapy, anthropometric or laboratory parameters, or measured REE was not available or if presenting with conditions known to affect indirect calorimetry.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Observational
- 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.
ObservationalOther
Also called Retrospective cohort study
Observational
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight in Kilograms
Measured: Baseline
Neck circumference
Neck circumference in cm
Measured: Baseline
Waist circumference
Waist circumference in cm
Measured: At baseline
Hip circumference
Hip circumference in cm
Measured: Baseline
Body mass index (BMI)
Body mass index (BMI) (expressed in kg/m^2)
Measured: At baseline
Resting Energy Expenditure (REE)
Resting Energy Expenditure (REE) in kcal
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Jun 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluigi Giannelli, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484883
- Sponsor's protocol ID
- 6/2020
- Status last verified
- Jul 2020
- First submitted
- 21 Jul 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- 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 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Six Equations for Estimating Resting Energy Expenditure in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04484883
- Acronym / sponsor ID
- 6/2020
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 Jul 2020 (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 present study evaluated the statistical and clinical performance of the six common equations in subjects with type 2 diabetes adopting indirect calorimetry as reference standard
Detailed description
All consecutive subjects with type 2 diabetes referred from June 2012 to December 2019 were eligible. They were excluded if data on ongoing therapy, anthropometric or laboratory parameters, or measured REE was not available or if presenting with conditions known to affect indirect calorimetry.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 250 patients (124 females and 126 males, mean age 61.9 ± 8.5 years)
Key inclusion criteria (2 listed)
- Patients with type 2 diabetes
- Available resting energy expenditure assessed by indirect calorimetry
Key exclusion criteria (2 listed)
- data on ongoing therapy (e.g. lifestyle measures with or without approved drugs), anthropometric or laboratory parameters (including white blood count, estimated glomerular filtration rate, TSH), or REE assessed by the means of indirect calorimetry could not be retrieved
- presenting with conditions known to affect indirect calorimetry (e.g. patients with strenuous exercise on the day before, asymptomatic patients with severe chronic kidney disease (eGFR < 30 ml/min/ 1.73 m2), increased white blood count, or subnormal TSH)
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 |
|---|---|---|
| ObservationalAlso: Retrospective cohort studyObservational | Other | – |
Primary outcome
Body weight
Time frame: Baseline
Body weight in Kilograms
Neck circumference
Time frame: Baseline
Neck circumference in cm
Waist circumference
Time frame: At baseline
Waist circumference in cm
Hip circumference
Time frame: Baseline
Hip circumference in cm
Body mass index (BMI)
Time frame: At baseline
Body mass index (BMI) (expressed in kg/m^2)
Resting Energy Expenditure (REE)
Time frame: At baseline
Resting Energy Expenditure (REE) in kcal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 28 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: Baseline). The study lists 6 primary outcomes in all. 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 28 Jul 2020.