Clinical trial NCT06757751: Antidiabetic Potential of Galician High-phenolic Extra Virgin Olive Oils in Patients With Type 2 Diabetes Mellitus.
Official title: Antidiabetic Potential of Galician High-phenolic Extra Virgin Olive Oils in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Fundacin Biomedica Galicia Sur
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Glycosylated hemoglobin (HbA1c)
timeFrame: At baseline, at 12 weeks and at 24 weeks
measure: Fasting plasma glucose (FPG)
timeFrame: At baseline, at 12 weeks and at 24 weeks
Secondary outcomes:
measure: Age
timeFrame: Baseline
measure: Sex at birth
timeFrame: Baseline
measure: Cardiovascular Risk Factors
timeFrame: Baseline
measure: Hepatic dysfunction
timeFrame: Baseline
measure: Previous heart disease
timeFrame: Baseline
measure: Heart failure
timeFrame: Baseline
measure: Coronary Heart Disease
timeFrame: Baseline
measure: Concomitant pharmacological treatment
timeFrame: Baseline
measure: Antidiabetic treatment
timeFrame: Baseline
measure: Systolic Blood Pressure
timeFrame: At baseline, at 12 weeks and at 24 weeks
measure: Diastolic blood pressure
timeFrame: At baseline, at 12 weeks and at 24 weeks
measure: Heart rate
timeFrame: At baseline, at 12 weeks and at 24 weeks
measure: Weight
timeFrame: At baseline, at 12 weeks and at 24 weeks
measure: Heigth
timeFrame: Baseline
measure: Body Mass Index (BMI)
timeFrame: Baseline
measure: Urinary albumin excretion (UAE)
timeFrame: At baseline, at 12 weeks and at 24 weeks
measure: Estimated Average Plasma Glucose
timeFrame: At baseline, at 12 weeks and at 24 weeks
measure: Fasting Insulin
timeFrame: At baseline, at 12 weeks and at 24 weeks
measure: Homeostatic Model Assessment for beta-cell function (HOMA-B)
timeFrame: At baseline, at 12 weeks and at 24 weeks
measure: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
timeFrame: At baseline, at 12 weeks and at 24 weeks
measure: N-terminal pro-B-type natriuretic peptide (NT-proBNP)
timeFrame: At baseline, at 12 weeks and at 24 weeks
measure: Total cholesterol
timeFrame: At baseline, at 12 weeks and at 24 weeks
measure: LDL-C HDL-C, mmol/l
timeFrame: At baseline, at 12 weeks and at 24 weeks
measure: HDL-C
timeFrame: At baseline, at 12 weeks and at 24 weeks
measure: Triglycerides (TG)
timeFrame: At baseline, at 12 weeks and at 24 weeks
measure: Dietetic education
timeFrame: At baseline, at 12 weeks and at 24 weeks
measure: Cardiovascular events
timeFrame: At 12 weeks and at 24 weeks
Other outcomes:
Locations:
city: Ourense
country: Spain
facility: Beatriz Cancho Grande
Study officials:
References: