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Completed

NCT Number: NCT06757751

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beatriz Cancho Grande

Ourense, 32004, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EVOO diet supplement

Dietary 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).

Primary outcomes

  1. Glycosylated hemoglobin (HbA1c)

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

  2. Fasting plasma glucose (FPG)

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

    mg/dl

Secondary outcomes

  1. Age

    Time frame: Baseline

    Years

  2. Sex at birth

    Time frame: Baseline

    Male/female

  3. Cardiovascular Risk Factors

    Time frame: 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)

  4. Hepatic dysfunction

    Time frame: Baseline

    Yes/No

  5. Previous heart disease

    Time frame: Baseline

    Yes/No

  6. Heart failure

    Time frame: Baseline

    Yes/No

  7. Coronary Heart Disease

    Time frame: Baseline

    Yes/No

    If yes, answer the following questions:

    • Acute coronary syndrome: Yes/No
    • Coronary revascularization: Yes/No

  8. Concomitant pharmacological treatment

    Time frame: 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

  9. Antidiabetic treatment

    Time frame: 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

  10. Systolic Blood Pressure

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

    mm Hg

  11. Diastolic blood pressure

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

    mm Hg

  12. Heart rate

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

    beats/minute

  13. Weight

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

    kg

  14. Heigth

    Time frame: Baseline

    cm

  15. Body Mass Index (BMI)

    Time frame: Baseline

    kg/m2

  16. Urinary albumin excretion (UAE)

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

    mg/24 h

  17. Estimated Average Plasma Glucose

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

    mg/dl

  18. Fasting Insulin

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

    µU/ml

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

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

  20. Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

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

    Adimensional

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

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

    pg/ml

  22. Total cholesterol

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

    mg/dl

  23. LDL-C HDL-C, mmol/l

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

    mg/dl

  24. HDL-C

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

    mg/dl

  25. Triglycerides (TG)

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

    mg/dl

  26. Dietetic education

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

    Visit with Dietitian: Yes/No

  27. Cardiovascular events

    Time frame: At 12 weeks and at 24 weeks

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

Sponsors and collaborators

Lead sponsor

Fundacin Biomedica Galicia Sur

Other

Registry information

Official study title

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

Acronym: OILDIABET

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 3, 2025
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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