Type 2 Diabetes Mellitus Clinical Trial
Official title:
Insulin Sensitivity and Metabolomics During Oral Administration of Glucose and a Graded Intravenous Infusion in Patients With Normal Glucose Tolerance, Impaired Glucose Tolerance and in Patients With Type 2 Diabetes Mellitus
Verified date | July 2019 |
Source | Catholic University of the Sacred Heart |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Bariatric surgery has been proven to be an effective treatment of type 2 diabetes and it has
highlighted to role of the small intestine in glucose homeostasis. Improvement of glucose
homeostasis occurs just a few days after the bariatric surgery, where parts of the small
intestine is bypassed, has been performed. Furthermore, conditioned medium from the duodenum
and the jejunum from both diabetic rodents and humans are able to induce insulin resistance
in normal mice and in myocytes. Hence the hypothesis is that the small intestine secretes
factors that are able to induce insulin resistance.
This project aims to study how orally ingested glucose is able to induce insulin resistance
and if this response differs in patients with normal glucose tolerance, impaired glucose
tolerance and in patients with type 2 diabetes mellitus. To address this question glucose
homeostasis will be studied by comparing whole body glucose uptake during a progressively
increased oral glucose load with a graded glucose infusion where the blood glucose levels
will be kept in the same range as during the oral glucose load in patients with normal
glucose tolerance, impaired glucose tolerance and patients with type 2 diabetes mellitus.
Previous studied have shown that different metabolites and bile acids could be involved the
regulation of glucose homeostasis. Hence, it is possible that the gut regulates metabolites
that could be involved in small intestine-induced insulin resistance described above. The aim
of this research is to study metabolomics in plasma collected during the oral glucose
tolerance test with increasing load of glucose and the graded glucose infusion where plasma
glucose level will be held in the same levels as during the oral glucose tolerance test and
study the differences in patients with normal glucose tolerance, impaired glucose tolerance
and in patients with type 2 diabetes mellitus.
The expected results in this study will demonstrate that the gut plays an important role in
glucose homeostasis and that this system is dysregulated in type 2 diabetes. More
importantly, novel factors derived or regulated from the gut that regulate insulin resistance
and glucose tolerance will be identified which could be possible targets for future
antidiabetic therapies.
Status | Completed |
Enrollment | 23 |
Est. completion date | January 31, 2019 |
Est. primary completion date | January 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Age between 20 and 65 - BMI between 35 and 60 kg/m2 - Ability to understand and comply with the study process. Exclusion Criteria: - History of type 1 diabetes or secondary diabetes; - Previous bariatric surgery; - History of medical problems such as mental impairment; - Major cardiovascular disease; - Major gastrointestinal disease; - Major respiratory disease; - Hormonal disorders; - Infection; - History of drug addiction and/or alcohol abuse; - Internal malignancy; - Pregnancy; - Suspected or confirmed poor compliance; |
Country | Name | City | State |
---|---|---|---|
Italy | Università Cattolica S. Cuore | Roma |
Lead Sponsor | Collaborator |
---|---|
Catholic University of the Sacred Heart | Steno Diabetes Center Copenhagen |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glucose kinetics | Whole body glucose uptake will be measured using a double glucose tracer technique during both the oral glucose tolerance test and the graded intravenous glucose infusion. | 1 year | |
Secondary | Metabolomics | Plasma levels of small polar metabolites, molecular lipids and conjugated and unconjugated bile acids will be measured during both oral glucose tolerance test and during the graded intravenous glucose infusion. | 1 year |
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