Contact information
Type
Scientific
Primary contact
Prof Mauro Giordano
ORCID ID
Contact details
Pzza L. Miraglia
2
Naples
80138
Italy
mauro.giordano@unina2.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
diab-07-0804
Study information
Scientific title
Acronym
DM2LPD study
Study hypothesis
Dietary protein restriction on albumin and fibrinogen synthesis.
Ethics approval
Approval received from the Ethics committee of Second University of Naples (Comitato Etico Azienda Ospedaliera Universitaria - SUN) in 2005.
Study design
Interventional, randomised prospective clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Diabetes mellitus and nephropathy
Intervention
We compared the effects of a Normal Protein Diet (NPD) (1.38 ± 0.08 g/kg/day) or a Low Protein Diet (LPD) (0.81 ± 0.04 g/kg/day) on Endogenous Leucine Flux (ELF), albumin and fibrinogen synthesis (5,5,5,-D3-L-leucine infusion), and markers of inflammation, in 9 subjects with DM2 and macroalbuminuria.
The duration of treatment is 4 weeks pre-LPD and 4 weeks post-LPD. The total duration of follow-up for all treatment arms is 8 weeks.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Albumin and fibrinogen synthesis, measured at baseline and four weeks pre-LPD and post-LPD.
Secondary outcome measures
Proteinuria and low-grade inflammation, measured at baseline and four weeks pre-LPD and post-LPD.
Overall trial start date
05/01/2005
Overall trial end date
07/07/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Eligibility criteria of type 2 diabetic patients included:
1. Body Mass Index (BMI) less than 35 kg/m^2
2. Proteinuria greater than 3 g/day
3. Absence of urinary tract infection or other renal diseases
Age range and gender of our participants are:
1. DM2 (60 ± 2 years): 6 males, 3 females
2. Control (37 ± 3 years): 3 males and 3 females
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
10
Participant exclusion criteria
Exclusion criteria of type 2 diabetic patients included:
1. BMI greater than 35 kg/m^2
2. Proteinuria less than 3 g/day
Recruitment start date
05/01/2005
Recruitment end date
07/07/2006
Locations
Countries of recruitment
Italy
Trial participating centre
Pzza L. Miraglia, 2
Naples
80138
Italy
Sponsor information
Organisation
Second University of Naples (Seconda Universita degli studi di Napoli) (Italy)
Sponsor details
Department of Geriatrics and Metabolism Diseases
Pzza l. miraglia
2
Naples
80138
Italy
mauro.giordano@unina2.it
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Second University of Naples (Seconda Universita degli studi di Napoli) (Italy) - Department of Geriatrics and Metabolism Diseases
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Italian Ministry for University and Scientific Research (MIUR) (Italy) (ref: PRIN prot. 2004060902_005)
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