Antidiabetic Potential of Galician High-phenolic Extra Virgin Olive Oils in Patients With Type 2 Diabetes Mellitus.

Fundacin Biomedica Galicia Sur116 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

116

Conditions

Diabetes Mellitus, Type 2

Interventions

EVOO diet supplementDIETARY_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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beatriz Cancho Grande

Ourense, Spain

Outcomes

Primary Outcomes

Glycosylated hemoglobin (HbA1c)

Time frame: At baseline, at 12 weeks and at 24 weeks

Fasting plasma glucose (FPG)

mg/dl

Time frame: At baseline, at 12 weeks and at 24 weeks

Secondary Outcomes

Age

Years

Time frame: Baseline

Sex at birth

Male/female

Time frame: Baseline

Cardiovascular Risk Factors

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)

Time frame: Baseline

Hepatic dysfunction

Yes/No

Time frame: Baseline

Previous heart disease

Yes/No

Time frame: Baseline

Heart failure

Yes/No

Time frame: Baseline

Coronary Heart Disease

Yes/No If yes, answer the following questions: * Acute coronary syndrome: Yes/No * Coronary revascularization: Yes/No

Time frame: Baseline

Concomitant pharmacological treatment

Data from ClinicalTrials.gov

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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

Time frame: Baseline

Antidiabetic treatment

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

Time frame: Baseline

Systolic Blood Pressure

mm Hg

Time frame: At baseline, at 12 weeks and at 24 weeks

Diastolic blood pressure

mm Hg

Time frame: At baseline, at 12 weeks and at 24 weeks

Heart rate

beats/minute

Time frame: At baseline, at 12 weeks and at 24 weeks

Weight

Time frame: At baseline, at 12 weeks and at 24 weeks

Heigth

Time frame: Baseline

Body Mass Index (BMI)

kg/m2

Time frame: Baseline

Urinary albumin excretion (UAE)

mg/24 h

Time frame: At baseline, at 12 weeks and at 24 weeks

Estimated Average Plasma Glucose

mg/dl

Time frame: At baseline, at 12 weeks and at 24 weeks

Fasting Insulin

µU/ml

Time frame: At baseline, at 12 weeks and at 24 weeks

Homeostatic Model Assessment for beta-cell function (HOMA-B)

Time frame: At baseline, at 12 weeks and at 24 weeks

Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

Adimensional

Time frame: At baseline, at 12 weeks and at 24 weeks

N-terminal pro-B-type natriuretic peptide (NT-proBNP)

pg/ml

Time frame: At baseline, at 12 weeks and at 24 weeks

Total cholesterol

mg/dl

Time frame: At baseline, at 12 weeks and at 24 weeks

LDL-C HDL-C, mmol/l

mg/dl

Time frame: At baseline, at 12 weeks and at 24 weeks

HDL-C

mg/dl

Time frame: At baseline, at 12 weeks and at 24 weeks

Triglycerides (TG)

mg/dl

Time frame: At baseline, at 12 weeks and at 24 weeks

Dietetic education

Visit with Dietitian: Yes/No

Time frame: At baseline, at 12 weeks and at 24 weeks

Cardiovascular events

It will be indicated if cardiovascular events have occurred: Yes/No

Time frame: At 12 weeks and at 24 weeks