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
Protocol serial number	03/2009
Sponsor	University of Palermo (Italy)
Funders	Ministry of Education and Research (Ministero dell'Università e della Ricerca [MURST]) (Italy), Onlus: Nutrition and Health (Associazione Onlus: Nutrizione e Salute) (Italy)

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 of protocol

Not provided at time of registration

Contact information

Prof Silvio Buscemi
Scientific

Department of Internal Medicine, Cardiovascular and Kidney Diseases
Via del Vespro, 129
Palermo
90127
Italy

Email	silbus@tin.it

Study information

Primary study design	Interventional
Study design	Longitudinal open label randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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 objectives	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)
Health condition(s) or problem(s) studied	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(s)	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).
Key secondary outcome measure(s)	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).
Completion date	01/01/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	80
Key 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
Key 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
Date of first enrolment	01/11/2010
Date of final enrolment	01/01/2012

Locations

Countries of recruitment

Italy

Study participating centre

Department of Internal Medicine, Cardiovascular and Kidney Diseases

Palermo
90127
Italy

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes