Diabetes Mellitus, Type 2
Conditions
Brief summary
Since Galician virgin olive oils have a high content of bioactive phenolic compounds and these are attributed to a large part of the healthy properties of the Mediterranean Diet, our starting hypothesis is that these olive oils could attenuate insulin resistance, improving glycemic control in terms of fasting plasma glucose and/or glycated hemoglobin and insulin sensitivity.
Interventions
DIETARY_SUPPLEMENTEVOO diet supplement
For 24 weeks, subjects in intervention arm will have their diet supplemented, daily, with an amount of 30 ml of EVOO (Extra Virgin Olive Oil).
Sponsors
Fundacin Biomedica Galicia Sur
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with type 2 diabetes mellitus for at least 1 year prior to inclusion. * Older than 18 years old * Current treatment with diet and/or oral hypoglycemic agents (biguanides, thiazolindiones, α-glucosidase inhibitors, iDPP4, aGLP-1, iSGLT2). * Body mass index ≥ 25 kg/m2 and \< 40 kg/ m2.
Exclusion criteria
* Patients on treatment with insulin, SU or rapid-acting insulin secretagogues. * History of severe ketosis or hyperglycemic decompensation. * Pregnancy, pregnancy planning or breastfeeding. * Body mass index ≥ 25 kg/m2 and \< 40 kg/m2. * Difficulty or great inconvenience in changing eating habits or a low predicted probability of changing eating habits. * Serious medical condition that may affect the person's ability to participate in a nutritional intervention study (e.g., digestive disease with fat intolerance, malignant disease, or significant neurological, psychiatric, or endocrine disease). * Any other medical condition considered to limit survival to less than 1 year. * Immunodeficiency or HIV positive status. * Illegal drug use, chronic alcoholism or problematic alcohol use or total daily alcohol intake \> 80 g/d. * Participation in any clinical trial or use of any investigational drug within the past year. * Patients institutionalized for chronic care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycosylated hemoglobin (HbA1c) | At baseline, at 12 weeks and at 24 weeks | — |
| Fasting plasma glucose (FPG) | At baseline, at 12 weeks and at 24 weeks | mg/dl |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Risk Factors | Baseline | Cardiovascular risk factors from the following list will be indicated: Arterial hypertension: Yes/No Dyslipidemia: Yes/No Smoking: Non-smoker Current smoker Recent ex-smoker (\<1year) Former smoker (≥1year) |
| Hepatic dysfunction | Baseline | Yes/No |
| Previous heart disease | Baseline | Yes/No |
| Heart failure | Baseline | Yes/No |
| Coronary Heart Disease | Baseline | Yes/No If yes, answer the following questions: * Acute coronary syndrome: Yes/No * Coronary revascularization: Yes/No |
| Concomitant pharmacological treatment | Baseline | The concomitant pharmacological treatment will be indicated by marking the appropriate one in the following list: Diuretics: Yes/No Mineralcorticoid receptor antagonists: Yes/No ACE inhibitors: Yes/No ARBs2: Yes/No Sacubitril/Valsartan: Yes/No Ivabradin: Yes/No Statins: Yes/No AntiPCSK9: Yes/No Ezetimibe: Yes/No Fibrates: Yes/No Antiaggregants: Yes/No Anticoagulants: Yes/No Beta-blockers: Yes/No Calcium antagonists: Yes/No Antiarrhythmics: Yes/No |
| Antidiabetic treatment | Baseline | Antidiabetic treatment: Yes/No If Yes, will indicate which of the following list: Metformin: Yes/No Sulfonylurea: Yes/No I-DPP4: Yes/No I-SGLT2: Yes/No ArGLP1: Yes/No Pioglitazone: Yes/No Insulin: Yes/No If insulin is Yes, which type of dose from the following list will be indicated: Basal (1); Two-dose NPH or premixes (2); Basal-bolus (3); Total daily dose: IU/day |
| Systolic Blood Pressure | At baseline, at 12 weeks and at 24 weeks | mm Hg |
| Diastolic blood pressure | At baseline, at 12 weeks and at 24 weeks | mm Hg |
| Heart rate | At baseline, at 12 weeks and at 24 weeks | beats/minute |
| Weight | At baseline, at 12 weeks and at 24 weeks | kg |
| Heigth | Baseline | cm |
| Age | Baseline | Years |
| Urinary albumin excretion (UAE) | At baseline, at 12 weeks and at 24 weeks | mg/24 h |
| Estimated Average Plasma Glucose | At baseline, at 12 weeks and at 24 weeks | mg/dl |
| Fasting Insulin | At baseline, at 12 weeks and at 24 weeks | µU/ml |
| Homeostatic Model Assessment for beta-cell function (HOMA-B) | At baseline, at 12 weeks and at 24 weeks | — |
| Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | At baseline, at 12 weeks and at 24 weeks | Adimensional |
| N-terminal pro-B-type natriuretic peptide (NT-proBNP) | At baseline, at 12 weeks and at 24 weeks | pg/ml |
| Total cholesterol | At baseline, at 12 weeks and at 24 weeks | mg/dl |
| LDL-C HDL-C, mmol/l | At baseline, at 12 weeks and at 24 weeks | mg/dl |
| HDL-C | At baseline, at 12 weeks and at 24 weeks | mg/dl |
| Triglycerides (TG) | At baseline, at 12 weeks and at 24 weeks | mg/dl |
| Dietetic education | At baseline, at 12 weeks and at 24 weeks | Visit with Dietitian: Yes/No |
| Cardiovascular events | At 12 weeks and at 24 weeks | It will be indicated if cardiovascular events have occurred: Yes/No |
| Body Mass Index (BMI) | Baseline | kg/m2 |
| Sex at birth | Baseline | Male/female |
Countries
Spain
Outcome results
None listed