Insulin Resistance Clinical Trial
Official title:
Impact of a Supplement of Vegetable Oils on Body Weight and Composition, Insulin Sensitivity and Other Cardiovascular Risk Factors in People at Risk of Developing Type 2 Diabetes Mellitus.
Verified date | October 2018 |
Source | University of Los Andes, Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Metabolic and cardiovascular diseases are the first cause of morbidity and mortality throughout the world, including Latin America and Colombia. Asymptomatic elevations of blood glucose, insufficient response to normal insulin concentrations (called insulin resistance), overweight and obesity can cause severe damage to body organs, leading to complications and even death. Worryingly, the prevalence of prediabetes is on the rise and efforts in public health policies made to contain this epidemic have had a very limited impact. This has prompted an intense search for non-pharmacological interventions. One of the most promising areas is research on "nutraceuticals", foods capable of positively impacting risk factors. However, there are insufficient nutritional or supplementary alternatives to favorably impact carbohydrate metabolism and cardiovascular risk factors in individuals at risk of diabetes. This project will evaluate the effects of the administration of a dietary supplement composed of vegetable oils. The fat composition of these oils is likely to impact positively on the metabolic profile of subjects at risk of diabetes and cardiovascular conditions.
Status | Completed |
Enrollment | 25 |
Est. completion date | October 2, 2018 |
Est. primary completion date | June 16, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age 18 or older. - Risk of type 2 diabetes (T2DM) given by BMI 25 kg/m2 or greater and / or Finnish Diabetes Risk Score(FinnRisc) greater than 12. - Manifest desire to participate in the study, and provision of informed consent. - Participants must continue their regular eating habits and physical activity. Exclusion Criteria: - Current participation in a systematic weight loss program. - Current use of medications that modify insulin sensitivity (except contraceptives in the case of women). - Known hypersensitivity to any component of the supplement. - Gastrointestinal problems that negatively affect the adherence to the study intervention. - Known complications from diabetes or hypertension: Coronary heart disease, nephropathy, retinopathy, cerebrovascular disease, diabetic foot or painful neuropathy. - Pregnancy. |
Country | Name | City | State |
---|---|---|---|
Colombia | University Of Los Andes Columbia | Bogotá | Cundinamarca |
Lead Sponsor | Collaborator |
---|---|
University of Los Andes, Columbia | Team Foods Colombia S.A. |
Colombia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Homeostasis Model Assessment - Insulin Resistance (HOMA-IR) | Change in the HOMA-IR index at week 8, relative to baseline. HOMA-IR is calculated as the product of the fasting glycemia in mmol/L and fasting insulinemia in microunits/mL, divided by the constant 22.5. | Measured at baseline and at week 8. | |
Secondary | Glycated hemoglobin A1c (HbA1c) | Change in the values of HbA1c at week 8, relative to baseline | Measured at baseline and at week 8. | |
Secondary | Body-mass index | Change in the patients' BMI at week 8, relative to baseline | Assessed at baseline and at week 8 | |
Secondary | Percent body fat. | Change in impedanciometry-estimated percent body fat at week 8, relative to baseline | Assessed at baseline and at week 8 | |
Secondary | Percent abdominal fat | Change in impedanciometry-estimated percent abdominal fat at week 8, relative to baseline. | Assessed at baseline and at week 8. | |
Secondary | Lean body mass. | Change in impedanciometry-estimated lean body mass. | Assessed at baseline and at week 8. | |
Secondary | Waist circumference. | Change in waist circumference | Assessed at baseline and at week 8. | |
Secondary | High-sensitivity C-reactive protein (hsCRP) | Change in plasma hsCRP. | Measured at baseline and at week 8. | |
Secondary | Pigment epithelium-derived factor (PEDF). | Change in plasma levels of PEDF, a biomarker of insulin resistance. | Measured at baseline and at week 8. | |
Secondary | Change in plasma adiponectin | Change in plasma levels of total adiponectin. | Measured at baseline and at week 8 | |
Secondary | Change in plasma FGF-21 | Change in plasma levels of Fibroblast growth factor 21 (FGF-21). | Measured at baseline and at week 8. |
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