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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT06757751
• Lead Sponsor: Fundacin Biomedica Galicia Sur

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-30
• Primary Completion: 2022-07-22
• Study Completion: 2022-09-30
• Study First Submitted: 2024-12-27
• Study First Submitted QC: 2024-12-27
• Status Verified: 2025-01
• Study First Posted: 2025-01-03
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Triglycerides (TG)	At baseline, at 12 weeks and at 24 weeks	mg/dl
Age	Baseline	Years
Sex at birth	Baseline	Male/female
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
Body Mass Index (BMI)	Baseline	kg/m2
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

Trial Locations

Locations (1)

Beatriz Cancho Grande; 🇪🇸 Ourense, Spain