Effects of hypocaloric diets at different glucose load on endothelial function and glycaemic variability in adult obese subjects with increased cardiovascular risk
| ISRCTN | ISRCTN56834511 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56834511 |
| Secondary identifying numbers | 03/2009 |
- Submission date
- 26/11/2010
- Registration date
- 16/12/2010
- Last edited
- 09/01/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Silvio Buscemi
Scientific
Scientific
Department of Internal Medicine, Cardiovascular and Kidney Diseases
Via del Vespro, 129
Palermo
90127
Italy
| silbus@tin.it |
Study information
| Study design | Longitudinal open label randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Effects of hypocaloric diets at different glucose load on endothelial function and glycaemic variability in adult obese subjects with increased cardiovascular risk: a longitudinal, open-label, randomised controlled trial |
| Study hypothesis | Different glycaemic index/glucose load nutritional aproaches to obesity, as well as weight loss per se, may have a different impact on endothelial function and on glycaemic homeostasis, two factors influencing both cardiovascular and diabetes risk. |
| Ethics approval(s) | Investigator Revisory Board of the University of Palermo approved on 12th February 2009 (ref. ORPA07R2ZF) |
| Condition | Cardiovascular and metabolic diseases; clinical nutrition |
| Intervention | Participants will be randomly assigned respectively to a hypocaloric low or high glucose-load diet. Both diet will have similar macronutrient composition. After three months of dieting participants will follow a similar body weight maintainance dietary treatment for 9 months. |
| Intervention type | Other |
| Primary outcome measure | 1. Endothelial function, measured as "flow mediated dilation" 2. Glycaemic variability, measured by the subcutaneous continuous glucose monitoring method These measurements will be obtained three times, respectively before (0 months), after hypocaloric diet (3 months) and body weight maintenance periods (12 months). |
| Secondary outcome measures | 1. Traditional anthropometric, metabolic and cardiovascular risk factors 2. Intra-renal haemodynamic measurements (resistance and pulsatility indexes) 3. Carotid intima-media thickness These measurements will be obtained three times, respectively before (0 months), after hypocaloric diet (3 months) and body weight maintenance periods (12 months). |
| Overall study start date | 01/11/2010 |
| Overall study end date | 01/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 subjects; the primary outcome "glycaemic variability" will be measured in only 30% of participants (about 24 subjects) |
| Participant inclusion criteria | 1. Male and female subjects 2. Range of age 18 - 60 years 3. Range of body mass index (BMI) 28 - 39.9 kg/m^2 4. Presence of at least one of the diagnostic criteria of the metabolic syndrome: 4.1. Waist circumference greater than 80 cm for women and 94 cm for men 4.2. Triglycerides greater than 150 mg/dl or use of lowering blood lipid drugs 4.3. High density lipoproteins (HDL)-cholesterol less than 50 mg/dl for women or 40 mg/dl for men 4.4. Blood pressure greater than 130 mmHg for systolic or greater than 85 mmHg for diastolic blood pressure 4.5. Fasting plasma glucose greater than 100 mg/dl |
| Participant exclusion criteria | 1. Type 1 or 2 diabetes 2. Gastro-intestinal, connective diseases 3. Chronic pancreatitis, liver cirrhosis, kidney stones, renal failure 4. Use of acetyl-salicylic acid (ASA), other antiplatelet drugs, statins, oral hypoglycemic drugs, nitrates, non-steroidal anti-inflammatory drugs (NSAIDS), corticosteroids, drugs interfering with coagulation, supplements with vitamins and anti-oxidants 5. Pregnancy or lactation in the last six months 6. Regular sport activity 7. Denial of informed consent |
| Recruitment start date | 01/11/2010 |
| Recruitment end date | 01/01/2012 |
Locations
Countries of recruitment
- Italy
Study participating centre
Department of Internal Medicine, Cardiovascular and Kidney Diseases
Palermo
90127
Italy
90127
Italy
Sponsor information
University of Palermo (Italy)
University/education
University/education
Department of Internal Medicine, Cardiovascular and Kidney Diseases
Via del Vespro, 129
Palermo
90127
Italy
| silbus@tin.it | |
| Website | http://portale.unipa.it/ |
"ROR" |
https://ror.org/044k9ta02 |
Funders
Funder type
Government
Ministry of Education and Research (Ministero dell'Università e della Ricerca [MURST]) (Italy)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Министерство образования и науки, Ministry of Education and Research, HM
- Location
- Estonia
Onlus: Nutrition and Health (Associazione Onlus: Nutrizione e Salute) (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2013 | Yes | No |
