Effects of dietary protein restriction on albumin and fibrinogen synthesis in macroalbuminuric Diabetes Mellitus type 2 (DM2) subjects

ISRCTN	ISRCTN50205911
DOI	https://doi.org/10.1186/ISRCTN50205911
Protocol serial number	diab-07-0804
Sponsor	Second University of Naples (Seconda Universita degli studi di Napoli) (Italy)
Funders	Second University of Naples (Seconda Universita degli studi di Napoli) (Italy) - Department of Geriatrics and Metabolism Diseases, Italian Ministry for University and Scientific Research (MIUR) (Italy) (ref: PRIN prot. 2004060902_005)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Mauro Giordano
Scientific

Pzza L. Miraglia, 2
Naples
80138
Italy

Email	mauro.giordano@unina2.it

Primary study design	Interventional
Study design	Interventional, randomised prospective clinical trial
Secondary study design	Randomised controlled trial
Scientific title	Effects of dietary protein restriction on albumin and fibrinogen synthesis in macroalbuminuric Diabetes Mellitus type 2 (DM2) subjects
Study acronym	DM2LPD study
Study objectives	Dietary protein restriction on albumin and fibrinogen synthesis.
Ethics approval(s)	Approval received from the Ethics committee of Second University of Naples (Comitato Etico Azienda Ospedaliera Universitaria - SUN) in 2005.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Albumin and fibrinogen synthesis, measured at baseline and four weeks pre-LPD and post-LPD.
Key secondary outcome measure(s)	Proteinuria and low-grade inflammation, measured at baseline and four weeks pre-LPD and post-LPD.
Completion date	07/07/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	10
Total final enrolment	15
Key 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
Key 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
Date of first enrolment	05/01/2005
Date of final enrolment	07/07/2006

Pzza L. Miraglia, 2

Naples
80138
Italy

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/01/2008	10/06/2021	Yes	No

10/06/2021: Publication reference and total final enrolment added.