Obesity Type 2 Diabetes MellitusMetabolic
What this study is
Simplified from ClinicalTrials.govStudying fully automated glucose clamping (ClampArt®) to set it up at a US clinical research center for measuring insulin sensitivity, or how well the body responds to insulin, in adults ages 18 to 65.
Read the original summary from ClinicalTrials.gov
This trial will establish fully-automated glucose clamping using state-of-the-art technology (ClampArt®) at a US based clinical research center
Study details
- Sponsor
- Profil Institut für Stoffwechselforschung GmbH
- Conditions
- Obesity Type 2 Diabetes Mellitus · Obese Adults · Type 2 Diabetes Mellitus
- Enrolling
- 50 people
- Starts
- 2027-02-01
- Est. completion
- 2028-02-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openProfil US
Webster, Texas, United States
- Karim Mohammed · Contact434-906-0450karim@tranquilconsulting.com
- Deborah Bates · Contact613-220-7076deborahb@tranquilconsulting.com
- Nedal Adi, MD · Principal investigator
Study team
Sponsor
Profil Institut für Stoffwechselforschung GmbH
Study ID 00/1284-ClampUS
Have questions? The record lists no central contact. Use Consider me and the site team can reach you, or find them through ClinicalTrials.gov ↗.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.