DiabetesDLWNCT02518581
Validation of the Doubly Labelled Water Method in Subjects With Type 2 Diabetes Mellitus
A study testing Doubly labelled water method in people with Diabetes, run by Profil Institut für Stoffwechselforschung GmbH at 1 site in Germany.
Trial summary
The present study is an exploratory trial to establish a feasible DLW (doubly labelled water) protocol for implementation in clinical trials conducted at Profil Institut für Stoffwechselforschung, investigating treatment options for overweight and obesity in populations with and without diabetic comorbidity. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Doubly labelled water method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- 12 Aug 2015to 23 Dec 2021
- Phase
- Interventional
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent obtained before any trial-related activities.
- Stable weight +/- 5% for at least 3 months prior screening visit.
- Male or female subject, 18-64 years of age, both inclusive.
- Body Mass Index (BMI) >= 25 kg/m2.
- Type 2 diabetes mellitus (as diagnosed clinically) ≥ 12 months.
- HbA1c <= 9 % at screening visit.
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- Stable treatment (>= 3 month) with
- Oral antidiabetics (OADs) (except OADs that are associated with a reduction in body weight (α-glucosidase inhibitors, sodium glucose transporter 2-inhibitors (SGLT2))) and/or
- basal insulin injections and/or
- a dietary regimen. Subjects on a basal-bolus insulin regimen will not be enrolled.
- Considered generally healthy (apart from type 2 diabetes mellitus and with the exception of conditions associated with diabetes mellitus or the metabolic syndrome, such as dyslipidaemia and hypertension) upon completion of medical history, physical examination, vital signs, and analysis of laboratory safety variables, as judged by the Investigator.
Who cannot join
- Clinical significant acute illness within 2 weeks before study procedures, including severe infections, as judged by the Investigator.
- Receipt of any investigational medicinal product within 3 months before trial related procedures.
- Mental incapacity or language barriers which preclude adequate understanding or cooperation, unwillingness to participate in the trial, known or suspected not to comply with study directives or not to be reliable or trustworthy, or subjects who in the opinion of their general practitioner or the Investigator should not participate in the trial.
- Use of diuretics.
- Intake of any other drug or dietary supplement that in the opinion of the Investigator may impair validity of energy expenditure assessments.
- Clinically significant abnormal biochemistry screening tests, as judged by the Investigator. In particular, elevated liver enzymes (AST or ALT > 3 times the upper limit of normal) or impaired renal function with an estimated Glomerular Filtration Rate (eGFR; estimate after CKD-EP) < 60 ml/min.
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- Clinically significant abnormal electrocardiogram (ECG) findings at screening, as judged by the Investigator.
- Positive alcohol breath test at screening visit.
- Significant history of alcoholism or drug abuse as judged by the Investigator or consuming more than 21 units of alcohol per week (one unit of alcohol equals about 330 ml of beer, one glass of wine of 120 ml, or 40 ml spirits).
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) who is not able or willing to refrain from smoking and use of nicotine substitute products during the study.
- Excessive consumption of coffee and tea (i.e. more than 5 cups/day), chocolate or beverages such as cola containing methylxanthine (caffeine, theophylline or theobromine) as judged by the investigator.
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures include surgical sterilisation, hormonal intrauterine devices (coil), oral hormonal contraceptives, sexual abstinence or a surgically sterilised partner).
- Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes, e.g., acromegaly or Cushing's syndrome.
- History of hyperosmolar crisis, diabetic coma, or severe hypoglycemia within the last 3 months prior to trial examinations.
- Use of weight-loss medication or any non-permitted antidiabetic medication that is associated with a reduction in body weight (α-glucosidase inhibitors, SGLT2-inhibitors) within 3 months before trial examination.
- Use of injectable anti-diabetic therapy (other than insulin), e.g. GLP-1 receptor agonists (glucagon-like peptide), within 3 months prior to screening.
- Steroid therapy other than topical application.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estimating Free-living Human Energy Expenditure - Validation of the Doubly Labelled Water Method in Subjects With Type 2 Diabetes Mellitus
The present study is an exploratory trial to establish a feasible DLW (doubly labelled water) protocol for implementation in clinical trials conducted at Profil Institut für Stoffwechselforschung, investigating treatment options for overweight and obesity in populations with and without diabetic comorbidity. The study aims at the practical validation of a 1-2-week DLW protocol in overweight and obese type 2 diabetic subjects.
Total Energy Expenditure (TEE) values as assessed by DLW will then be compared to (1) TEE as calculated based on individual anthropometric measurements (including body composition) using the Müller formula and the AEE (activity related energy expenditure) based on reported work place and leisure time activities and (2) TEE as calculated from measured REE (resting energy expenditure) as assessed by indirect calorimetry and the AEE based on information recorded by the subjects in a physical activity diary and corresponding pedometer counts. Moreover, TEE assessments will be repeated once (separated by 2-4 weeks) to determine intra-subject variability / re-test reliability of the measurement.
- Conditions
- Diabetes
- Being tested
- Doubly labelled water method
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doubly labelled water methodProcedure or surgery
DLW (doubly labeled water) method measures isotope dilution spaces and elimination rates to assess total energy expenditure (TEE). After enriching the body water of a subject with DLW (2H and 18O), it is only necessary to collect urine samples at defined time points, usually over a period of 1-2 weeks, so that the measurement can be done in individuals able to engage in their typical habits without restrictions. The resulting TEE measurement represents an integral value over the measurement period.
| Study group | Role | What they receive |
|---|---|---|
| Doubly labelled water | Other | Not described Receives: Procedure: Doubly labelled water method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free-living total energy expenditure
Assessed by doubly labelled water
Measured: up to 3 month
Resting energy expenditure
Assessed by indirect calorimetry
Measured: up to 3 month
Activity-induced energy expenditure
Assessed by diary and pedometer
Measured: up to 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study start12 Aug 2015
- Primary completion23 Dec 2021
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tim Heise, MD, Principal investigator, Profil Institut für Stoffwechselforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518581
- Sponsor's protocol ID
- OBDM-03
- Acronym
- DLW
- Status last verified
- Dec 2021
- First submitted
- 3 Aug 2015
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimating Free-living Human Energy Expenditure - Validation of the Doubly Labelled Water Method in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02518581
- Acronym / sponsor ID
- DLW / OBDM-03
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbHIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2015 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 10 Aug 2015 (estimated)
- 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 is an exploratory trial to establish a feasible DLW (doubly labelled water) protocol for implementation in clinical trials conducted at Profil Institut für Stoffwechselforschung, investigating treatment options for overweight and obesity in populations with and without diabetic comorbidity. The study aims at the practical validation of a 1-2-week DLW protocol in overweight and obese type 2 diabetic subjects.
Total Energy Expenditure (TEE) values as assessed by DLW will then be compared to (1) TEE as calculated based on individual anthropometric measurements (including body composition) using the Müller formula and the AEE (activity related energy expenditure) based on reported work place and leisure time activities and (2) TEE as calculated from measured REE (resting energy expenditure) as assessed by indirect calorimetry and the AEE based on information recorded by the subjects in a physical activity diary and corresponding pedometer counts. Moreover, TEE assessments will be repeated once (separated by 2-4 weeks) to determine intra-subject variability / re-test reliability of the measurement.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doubly labelled water | Other | Procedure: Doubly labelled water method |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Signed informed consent obtained before any trial-related activities.
- Stable weight +/- 5% for at least 3 months prior screening visit.
- Male or female subject, 18-64 years of age, both inclusive.
- Body Mass Index (BMI) >= 25 kg/m2.
- Type 2 diabetes mellitus (as diagnosed clinically) ≥ 12 months.
Key exclusion criteria (17 listed)
- Clinical significant acute illness within 2 weeks before study procedures, including severe infections, as judged by the Investigator.
- Receipt of any investigational medicinal product within 3 months before trial related procedures.
- Mental incapacity or language barriers which preclude adequate understanding or cooperation, unwillingness to participate in the trial, known or suspected not to comply with study directives or not to be reliable or trustworthy, or subjects who in the opinion of their general practitioner or the Investigator should not participate in the trial.
- Use of diuretics.
- Intake of any other drug or dietary supplement that in the opinion of the Investigator may impair validity of energy expenditure assessments.
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 |
|---|---|---|
| Doubly labelled water methodDLW (doubly labeled water) method measures isotope dilution spaces and elimination rates to assess total energy expenditure (TEE). After enriching the body water of a subject with DLW (2H and 18O), it is only necessary to collect urine samples at defined time points, usually over a period of 1-2 weeks, so that the measurement can be done in individuals able to engage in their typical habits without restrictions. The resulting TEE measurement represents an integral value over the measurement period. | Procedure or surgery | Doubly labelled water |
Primary outcome
Free-living total energy expenditure
Time frame: up to 3 month
Assessed by doubly labelled water
Resting energy expenditure
Time frame: up to 3 month
Assessed by indirect calorimetry
Activity-induced energy expenditure
Time frame: up to 3 month
Assessed by diary and pedometer
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 29 Dec 2021.
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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.
Tim Heise, MD principal investigator
Profil Institut für Stoffwechselforschung GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doubly labelled water method in people with Diabetes, run by Profil Institut für Stoffwechselforschung GmbH at 1 site in Germany.
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 11 inclusion and 17 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 29 Dec 2021. 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 Germany. 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?
Free-living total energy expenditure (time frame: up to 3 month). The study lists 3 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 29 Dec 2021.