Effect of olive oil enriched in oleanolic acid on the incidence of type 2 diabetes mellitus in patients with pre-diabetes

Phase 2

Completed

• Conditions: Nutritional, Metabolic, Endocrine; Type 2 diabetes mellitus; Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN03372660
• Lead Sponsor: Andalusian Regional Ministry of Health (Consejería de Salud de la Junta de Andalucía) (Spain)

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31364228 (added 01/08/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-03
• Study Completion: 2009-12-31
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

Current information as of 09/11/09:
1. Men or women with an age range between 30 and 80 years
2. Body mass index = 25 kg/m^2 and < 40 kg/m^2
3. Acceptance to participate in the study and signed the corresponding informed consent

Initial information at time of registration:
1. Men or women with an age range between 30 and 80 years
2. Body mass index = 25 kg/m^2
3. Acceptance to participate in the study and signed the corresponding informed consent

Exclusion Criteria

Current information as of 09/11/09:
1. Diabetes at the time of admission to the study:
1.1. Glycaemia baseline = 126 mg/dl or glycaemia 2 hours after the oral overload
1.2. 75 g of glucose = 200 mg/dl
1.3. Diabetes confirmed by a physician and confirmed by other clinical data
1.4. In antidiabetic treatment (oral and/or insulin)
2. Alcohol dependence syndrome or any other addiction
3. Physical, mental or intellectual limitation to take part in a study of dietary intervention
4. Difficulty or lack of predisposition to change food habits
5. Drugs or medical conditions that interfere with the diagnosis of diabetes:
5.1. Beta-blockers
5.2. Systemic glucocorticoids
5.3. Selective inhibitors of the reuptake of serotonin at doses indicated for weight reduction
5.4. Other drugs for weight reduction (orlistat and sibutramine)
5.5. Thyroid Disease suboptimal treatment
5.6. Other endocrine diseases (such as Cushing's disease, acromegaly)
5.7. Fasting triglycerides > 600 mg/dl despite treatment
6. Conditions or circumstances which may affect the conduct of the trial:
6.1. Inability to communicate with the researchers conducting the intervention
6.2. Not willing to accept the treatment assigned by randomisation
6.3. Participation in another project that could interfere with this project
6.4. Loss of weight for any reason superior to 10 % in the last three months, except postpartum
6.5. Inability to walk 400 meters in 10 minutes without stopping
7. Cancer in the last 5 years that needed treatment, unless the prognosis is good
8. Systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 110 mmHg
9. Pregnant women of childbearing age, if:
9.1. Currently pregnant or within 3 months postpartum
9.2. Lactating
9.3. Pregnancy planned during the study period

Initial information at time of registration
1. Diabetes at the time of admission to the study:
1.1. Glycaemia baseline = 126 mg/dl or glycaemia 2 hours after the oral overload
1.2. 75 g of glucose = 200 mg/dl
1.3. Diabetes confirmed by a physician and confirmed by other clinical data
1.4. In antidiabetic treatment (oral and/or insulin)
2. Alcohol dependence syndrome or any other addiction
3. Physical, mental or intellectual limitation to take part in a study of dietary intervention
4. Difficulty or lack of predisposition to change food habits
5. Drugs or medical conditions that interfere with the diagnosis of diabetes:
5.1. Thiazide diuretics
5.2. Beta-blockers
5.3. Systemic glucocorticoids
5.4. Selective inhibitors of the reuptake of serotonin at doses indicated for weight reduction
5.5. Other drugs for weight reduction (orlistat and sibutramine)
5.6. Thyroid Disease suboptimal treatment
5.7. Other endocrine diseases (such as Cushing's disease, acromegaly)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of diabetes, diagnosed according to basal blood glucose or oral glucose overload, conducted every 6 months or 12 months respectively after entry into the study, according to recent criteria of the American Diabetes Association (ADA) (a fasting plasma glucose = 126 mg/dl or symptoms of hyperglycaemia and casual plasma glucose = 200 mg/dl or a plasma glucose value at 2 hours after an oral overload of 75 g of glucose = 200 mg/dl. In the absence of unequivocal hyperglycaemia, these criteria should be confirmed by repeating the test on a different day.)