Insulin Resistance Clinical Trial
— IRACTIVOfficial title:
Seeking a Link Between the Capacity of Peripheral Mononuclear Cells to Induce Insulin Resistance and the Development of Hyperinsulinemia in a General Population
Verified date | November 2023 |
Source | Centre Hospitalier Universitaire de Nimes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a two-center proof-of-concept study, ancillary to the MetACTIV study, whose objective is to define immune activation profiles from the data of individuals followed by the Caisse Primaire d'Assurance Maladie du Gard (health insurance fund). The IRACTIV study will include a subset of volunteers from the MetACTIV study for whom a blood sample will be taken as part of the IRACTIV study.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 5, 2023 |
Est. primary completion date | October 5, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Individuals who participated in the MetACTIV study. - Profile 2 subgroup-specific inclusion criteria: - MetACTIV study individual with a Profile 2. - Persons who have given free informed consent. - Persons who have signed the consent form. - Persons affiliated to or benefiting from a health insurance plan. - Adults (=18 years of age). Exclusion Criteria: - Persons participating in Category 1 research involving human subjects - Persons in an exclusion period as determined by another study. - Persons under court protection, guardianship or trusteeship. - Persons who are incapable of giving consent. - Persons for whom it is impossible to give clear information. - Pregnant, parturient or breastfeeding woman. |
Country | Name | City | State |
---|---|---|---|
France | Caisse Primaire d'Assurance Maladie du Gard | Nîmes | Gard |
France | Centre Hospitalier Universitaire | Nîmes | Gard |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes | Caisse Primaire d'Assurance Maladie du Gard |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Age of Profile 2 patients | In years | Day 0 | |
Other | Weight of profile 2 patients | In kg | Day 0 | |
Other | Gender of Profile 2 patients | male / female | Day 0 | |
Other | Waist measurement of Profile 2 patients | In cm | Day 0 | |
Other | Hip circumference of Profile 2 patients | In cm | Day 0 | |
Other | Systolic blood pressure in Profile 2 patients | In mmHg | Day 0 | |
Other | Diastolic blood pressure in Profile 2 patients | In mmHg | Day 0 | |
Other | High-density lipoproteins in Profile 2 patients | mM/L | Day 0 | |
Other | Low-density lipoproteins in Profile 2 patients | mM/L | Day 0 | |
Other | Triglycerides in Profile 2 patients | mM/L | Day 0 | |
Other | Hemoglobin A1c in Profile 2 patients | mM/L | Day 0 | |
Primary | Fasting blood glucose | Fasting blood glucose will be measured during a routine health evaluation and measured in mM/L. | Day 0 | |
Primary | End-of-study insulinemia | The amount of insulin in the blood of patients will be measured during a routine health evaluation and measured in µU/L. | Month 18 | |
Primary | Effect of peripheral blood mononuclear cell supernatant on intensity of the signal induced by insulin in hepatocytes. | Peripheral blood mononuclear cells are isolated on a Ficoll gradient and frozen. These frozen peripheral blood mononuclear cells will be sent to the Institute of Human Genetics for culture and supernatants will be recovered after 48 hours. The effect of these supernatants on insulin signaling will then be tested. To do so, they will be added or not to cultured HepG2 cells stimulated 24 hours later by 10nM insulin. After stimulation, HepG2 cells will be lysed and their total Akt and phosphorylated Akt content measured by ELISA and Western Blot. The proportion of phosphorylated Akt in HepG2 cells exposed to peripheral blood mononuclear cells supernatant will be compared with the proportion of phosphorylated Akt in HepG2 cells not exposed to peripheral blood mononuclear cells supernatant and expressed as the percentage of insulin signaling inhibition induced by the peripheral blood mononuclear cells supernatant. | Hour 48 | |
Secondary | A. Percentage inhibition of Akt phosphorylation in Profile 2 patients compared with other immune profiles. | The decrease in signal intensity induced in hepatocytes by insulin induced by peripheral blood mononuclear cell supernatant from volunteers with Profile 2 will be compared to the decrease in this intensity induced by peripheral blood mononuclear cell supernatant from volunteers with another immune activation Profile. Measured as a percentage. | Hour 48 | |
Secondary | B. Increase in insulinemia over time in Profile 2 patients compared with other immune profiles. | Insulinemia in Profile 2 volunteers, measured in µU/mL, will be compared with that of other immune profiles. | Month 18 |
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