Obesity Type 2 Diabetes MellitusNCT07913698
Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
An observational study of Obesity Type 2 Diabetes Mellitus and Obese Adults, run by Profil Institut für Stoffwechselforschung GmbH at 1 site in United States.
Trial summary
This trial will establish fully-automated glucose clamping using state-of-the-art technology (ClampArt®) at a US based clinical research center Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity Type 2 Diabetes Mellitus, Obese Adults, Type 2 Diabetes Mellitus
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2027to 1 Feb 2028
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese individuals and people with type 2 diabetes mellitus
Who may be able to join
- Signed and dated informed consent has been obtained
- Participant is male or female
- Age between 18 and 65 years, both inclusive
- Obese people or people diagnosed with type 2 diabetes
- BMI, > 30 kg/m2, for obese participants and people with type 2 diabetes
- Has venous access sufficient to allow cannulation for blood sampling as required by the protocol
Who cannot join
- Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomisation in this trial.
- Previous participation in this trial. Participation is defined as having completed at least one clamp.
- History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
- Clinically relevant comorbidity, capable of constituting a risk for the participant when participating in the trial or of interfering with the interpretation of data
- Any serious systemic infectious disease within the last four weeks, as judged by the investigator
- Signs of acute illness as judged by the investigator
Show all 17Show fewer
- Clinically significant abnormal screening laboratory tests, as judged by the investigator.
- Clinically significant abnormal findings for vital signs and ECG recordings, as judged by the investigator
- Significant history of alcoholism as judged by the investigator or consuming more than 24.0 grams alcohol/day (for males), 12.0 grams alcohol/day (for females) on average
- A positive result in the alcohol and/or urine drug screen at the screening visit.
- Daily smoker or using nicotine substitute products
- Tested positive for hepatitis Bs antigen
- Tested positive for hepatitis C antibodies. (Presence of hepatitis C antibodies will not lead to exclusion if liver function tests are normal and a hepatitis C polymerase chain reaction is negative)
- Positive result to the test for HIV-1/2 antibodies or HIV-1 antigen
- Current use of systemic medication that could interfere with the interpretation of the trial endpoints (insulin sensitivity assessment), as judged by the Investigator
- Blood donation or blood loss of more than 500 mL within the last 3 months
- If female, pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Profil US
Webster, Texas, 77598
Karim Mohammed, 434-906-0450, karim@tranquilconsulting.com
Deborah Bates, 613-220-7076, deborahb@tranquilconsulting.com
About this study
This trial will establish fully-automated glucose clamping using state-of-the-art technology (ClampArt®) at a US based clinical research center
Read the detailed description
Research aims of this trial are to quantify differences in insulin sensitivity between different study populations (obese vs. type 2 diabetes), to quantify the intraindividual variability in the different populations for optimizing future sample size estimates and to investigate the effect of prolonged insulin infusion on steady state glucose disposal.
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
GIR
M-value; mean glucose infusion rate (GIR, mg/kg/min)) during 30-minute observation periods
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity Type 2 Diabetes MellitusStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913698
- Sponsor's protocol ID
- 00/1284-ClampUS
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
- ClinicalTrials.gov ID
- NCT07913698
- Acronym / sponsor ID
- 00/1284-ClampUS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 3 Nov 2026 (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.
This trial will establish fully-automated glucose clamping using state-of-the-art technology (ClampArt®) at a US based clinical research center
Detailed description
Research aims of this trial are to quantify differences in insulin sensitivity between different study populations (obese vs. type 2 diabetes), to quantify the intraindividual variability in the different populations for optimizing future sample size estimates and to investigate the effect of prolonged insulin infusion on steady state glucose disposal.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese individuals and people with type 2 diabetes mellitus
Key inclusion criteria (6 listed)
- Signed and dated informed consent has been obtained
- Participant is male or female
- Age between 18 and 65 years, both inclusive
- Obese people or people diagnosed with type 2 diabetes
- BMI, > 30 kg/m2, for obese participants and people with type 2 diabetes
Key exclusion criteria (17 listed)
- Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomisation in this trial.
- Previous participation in this trial. Participation is defined as having completed at least one clamp.
- History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
- Clinically relevant comorbidity, capable of constituting a risk for the participant when participating in the trial or of interfering with the interpretation of data
- Any serious systemic infectious disease within the last four weeks, as judged by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
GIR
Time frame: 30 minutes
M-value; mean glucose infusion rate (GIR, mg/kg/min)) during 30-minute observation periods
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 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Obesity Type 2 Diabetes Mellitus and Obese Adults, run by Profil Institut für Stoffwechselforschung GmbH at 1 site in United States.
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 6 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: opening soon, as of the sponsor's last update on 3 Nov 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 United States. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GIR (time frame: 30 minutes). 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 3 Nov 2026.