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Not yet recruitingNCT07913698Updated Nov 3, 2026

Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology

An observational study in Obesity Type 2 Diabetes Mellitus, Obese Adults and Type 2 Diabetes Mellitus, sponsored by Profil Institut für Stoffwechselforschung GmbH. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Profil Institut für Stoffwechselforschung GmbH · Observational

Updated Nov 3, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 3,300 studies in Diabetes Mellitus, Type 2 with a site in United States — 340 open to participants now, 475 under way, 47 of them phase 3. Diabetes Mellitus, Type 2 · United States.

Planned enrollment
221st of 336
50 · median 128
Started
2027
with 7 others
Observational
336 of 3,300
38 open now
Primary completion
2028-02
later than 359 of 473 live
Registered
3,297th of 3,300
by date

Among the 3,300 studies in Diabetes Mellitus, Type 2 with a site in United States, this one is the 221st largest by planned enrollment of the 336 observational ones, is one of 8 that started in 2027, is one of 336 observational ones, reaches primary completion later than 359 of the 473 other live ones, and was the 3,297th registered.

By phase

3,300 studies; the count open now beside each. This study's row is marked.

No phase1,240 · 201 open
Phase 3576 · 30 open
Phase 2391 · 24 open
Phase 1383 · 24 open
Observationalthis study336 · 38 open
Phase 4300 · 19 open
Phase 1/240 · 3 open
Phase 2/333 · 1 open
Other kind1 · 0 open

By the year they started

First in 1976; this study’s year is marked. 8 started in 2027.

Size and results

Median enrollment 90 across the 2,953 interventional studies, 128 across the 336 observational. Of the 2,648 that completed or were terminated, 1,165 (44%) have results posted.

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02

Study summary

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.

03

Conditions studied

  • Obesity Type 2 Diabetes Mellitus
  • Obese Adults
  • Type 2 Diabetes Mellitus
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Obese individuals and people with type 2 diabetes mellitus

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed and dated has been obtained
  2. Participant is male or female
  3. Age between 18 and 65 years, both inclusive
  4. Obese people or people diagnosed with type 2 diabetes
  5. , > 30 kg/m2, for obese participants and people with type 2 diabetes
  6. Has venous access sufficient to allow cannulation for blood sampling as required by the protocol

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Previous participation in this trial. Participation is defined as having completed at least one clamp.
  3. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
  4. comorbidity, capable of constituting a risk for the participant when participating in the trial or of interfering with the interpretation of data
  5. Any serious systemic infectious disease within the last four weeks, as judged by the investigator
  6. Signs of acute illness as judged by the investigator
  7. Clinically significant abnormal screening laboratory tests, as judged by the investigator.
  8. Clinically significant abnormal findings for vital signs and recordings, as judged by the investigator
  9. 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
  10. A positive result in the alcohol and/or urine drug screen at the screening visit.
  11. Daily smoker or using nicotine substitute products
  12. Tested positive for hepatitis Bs antigen
  13. Tested positive for 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)
  14. Positive result to the test for -1/2 antibodies or HIV-1 antigen
  15. Current use of systemic medication that could interfere with the interpretation of the trial endpoints (insulin sensitivity assessment), as judged by the Investigator
  16. Blood donation or blood loss of more than 500 mL within the last 3 months
  17. If female, pregnancy or breast-feeding
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. GIR

    M-value; mean glucose infusion rate (GIR, mg/kg/min)) during 30-minute observation periods

    Time frame: 30 minutes

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2027; primary completion for Feb 2028, 12 months later.

Of 170 industry-sponsored observational studies under Diabetes Mellitus, Type 2, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 44. This study's planned 12 months is below that.

Counting every sponsor, half of 602 studies reached it within 32 months; a quarter within 17 and three quarters within 62.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2026
First posted
Nov 3, 2026
StartEst.
Feb 1, 2027
Primary completionEst.
Feb 1, 2028
CompletionEst.
Feb 1, 2028
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07913698
Responsible party
Sponsor
First posted
Nov 3, 2026
Start date
Feb 1, 2027 (estimated)
Primary completion
Feb 1, 2028 (estimated)
Completion
Feb 1, 2028 (estimated)
Last update
Nov 3, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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