Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/11/2010
Date assigned
16/12/2010
Last edited
09/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Silvio Buscemi

ORCID ID

Contact details

Department of Internal Medicine
Cardiovascular and Kidney Diseases
Via del Vespro
129
Palermo
90127
Italy
silbus@tin.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

03/2009

Study information

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

Acronym

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

Investigator Revisory Board of the University of Palermo approved on 12th February 2009 (ref. ORPA07R2ZF)

Study design

Longitudinal open label randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/11/2010

Overall trial end date

01/01/2012

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

80 subjects; the primary outcome "glycaemic variability" will be measured in only 30% of participants (about 24 subjects)

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

Trial participating centre

Department of Internal Medicine, Cardiovascular and Kidney Diseases
Palermo
90127
Italy

Sponsor information

Organisation

University of Palermo (Italy)

Sponsor details

Department of Internal Medicine
Cardiovascular and Kidney Diseases
Via del Vespro
129
Palermo
90127
Italy
silbus@tin.it

Sponsor type

University/education

Website

http://portale.unipa.it/

Funders

Funder type

Government

Funder name

Ministry of Education and Research (Ministero dell'Università e della Ricerca [MURST]) (Italy)

Alternative name(s)

Ministry of Education and Research

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Estonia

Funder name

Onlus: Nutrition and Health (Associazione Onlus: Nutrizione e Salute) (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23111004

Publication citations

  1. Results

    Buscemi S, Cosentino L, Rosafio G, Morgana M, Mattina A, Sprini D, Verga S, Rini GB, Effects of hypocaloric diets with different glycemic indexes on endothelial function and glycemic variability in overweight and in obese adult patients at increased cardiovascular risk., Clin Nutr, 2013, 32, 3, 346-352, doi: 10.1016/j.clnu.2012.10.006.

Additional files

Editorial Notes