Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
15 participants
INTERVENTIONAL
2014-11-30
2017-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Beta Cell Imaging in T1D Patients With a Different Glycemic Control
NCT03785275
Glucose-stimulated Pancreatic Islet and Intestinal Blood Flow in Healthy Subjects and in Type 1 Diabetes
NCT02547337
Activation Innate Immune System in Type 1 Diabetes
NCT03441919
Lipid and Glycogen Metabolism in Patients With Impaired Glucose Tolerance and Calcium Sensing Receptor Mutations
NCT02023489
Non-enhanced Magnetic Resonance Angiography of Diabetic Ischemic Lower Limbs
NCT01614379
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
White adipose tissue is increasingly considered a key metabolic organ in the development of insulin resistance. Especially the distribution of adipose tissue in the body is important. Indeed, visceral adipose tissue is a risk factor for coronary heart disease, certain cancers and T2D and associated with an increased cardiovascular and all-cause mortality, whereas excess of subcutaneous adipose tissue is not. There are distinct differences in the functional and hormonal characteristics of VAT and SAT, which may explain part of the mechanisms underlying the development of insulin resistance.
A more complete understanding of the molecular mechanisms that lead to T2D will enable the identification of individuals at highest risk, which could lead to more targeted prevention and pharmacological therapy.
FDG PET/CT is an established tomographic technique to image glucose metabolism with validated applications in oncology, infectious and inflammatory diseases, brain metabolism and cardiac viability. Several studies exploring the usefulness of FDG PET in imaging glucose metabolism in white adipose tissue reported lower overall glucose uptake in obese than in lean subjects. In both subject groups, glucose uptake was higher in VAT than in SAT. Glucose uptake in VAT and SAT was inversely related to insulin resistance, but uptake in GFAT was not. There are only few studies analyzing glucose uptake in patients with T2D with FDG PET/CT. In one study the impact of abdominal obesity and newly diagnosed T2D on insulin action in adipose tissue was evaluated, suggesting an excess of SAT to provide a sink for glucose, and thereby resulting in a compensatory decrease in insulin resistance. More research is needed to demonstrate the differences in glucose uptake in various adipose tissue depots in patients with T2D and correlate it with insulin resistance.
In order to keep glucose at a constant level during the FDG PET examination, usually a hyperinsulinemic euglycaemic glucose clamp is performed before scanning. Recently, a case-report was published describing an FDG PET/CT during an iatrogenic hypoglycemic state in a non-diabetic patient, which demonstrated remarkably increased glucose uptake in VAT and SAT. Based on this observation we hypothesize that glucose uptake during a hypoglycaemic state will be more pronounced in various adipose tissue depots. To our knowledge, this has not been performed in healthy volunteers or in patients with T2D. A controlled hypoglycemic state may be achieved by a hyperinsulinemic hypoglycaemic clamp, which has been used in several clinical studies. A demonstration of differences in FDG uptake in white adipose tissue between healthy volunteers and T2D patients and between VAT, SAT and GFAT under hypoglycaemic conditions would provide more insight in the glucose metabolism of adipose tissue and contribute to our understanding of insulin resistance in T2D. Even more importantly, this imaging technique might help to better characterise patients with T2D or patients at risk to develop T2D, and may thereby help to increase our understanding of the pathophysiology of T2D and the metabolic syndrome, which could lead to more targeted prevention in patients at risk and to personalised pharmacological therapy after the onset of clinically overt disease.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Healthy euglycemic clamp
In 5 healthy volunteers an 18F-FDG PET/CT will be performed during an euglycemic clamp
18F-FDG PET/CT
18F-FDG PET/CT
euglycemic clamp
euglycemic clamp
healthy hypoglycemic clamp
In 5 healthy volunteers an 18F-FDG PET/CT will be performed during a hypoglycemic clamp
18F-FDG PET/CT
18F-FDG PET/CT
hypoglycemic clamp
hypoglycemic clamp
Type 2 diabetes hypoglycemic clamp
In 5 type 2 diabetes patients, an 18F-FDG PET/CT will be performed during a hypoglycemic clamp
18F-FDG PET/CT
18F-FDG PET/CT
hypoglycemic clamp
hypoglycemic clamp
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
18F-FDG PET/CT
18F-FDG PET/CT
euglycemic clamp
euglycemic clamp
hypoglycemic clamp
hypoglycemic clamp
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BMI 27-40
For healthy volunteers:
* Fasting blood glucose \< 6.1 mmol/L
* HbA1c \< 42 mmol/mol (6%)
For T2D patients:
* Clinical overt Type 2 Diabetes
* on a glucose-lowering diet or on oral glucose-lowering medication
* T2D stable and under control for minimal 2 years
* HbA1c \< 75 mmol/mol (9%)
Exclusion Criteria
* Overt symptomatic neuropathy or proliferative retinopathy
* A history of cardiovascular disease complications (myocardial infarction, stroke, peripheral artery disease)
* Pregnancy or lactating
* Using subcutaneous insulin
* Incapability to provide informed consent
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Radboud University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Martin Gotthardt, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
RadboudUMC
Nijmegen, Gelderland, Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NL44098.091.13
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.