Condition category
Nutritional, Metabolic, Endocrine
Date applied
06/09/2007
Date assigned
19/11/2007
Last edited
19/11/2007
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 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

http://web.unina2.it/

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

Publication citations

Additional files

Editorial Notes