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Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes (SAMBA)

This study is currently recruiting participants.
Verified March 2017 by Giuseppe Pugliese, Metabolic Fitness Association, Italy
Sponsor:
ClinicalTrials.gov Identifier:
NCT01600924
First Posted: May 17, 2012
Last Update Posted: March 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of Roma La Sapienza
Information provided by (Responsible Party):
Giuseppe Pugliese, Metabolic Fitness Association, Italy
  Purpose
This project will assess the independent predictors of impaired muscle and bone strength through a longitudinal observation of a cohort of subjects with type 1 and 2 diabetes consecutively attending an outpatients diabetes clinics for the annual screening of complications.

Condition
Type 1 Diabetes Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes

Resource links provided by NLM:


Further study details as provided by Giuseppe Pugliese, Metabolic Fitness Association, Italy:

Primary Outcome Measures:
  • Independent predictors of reduced muscle and bone strength [ Time Frame: 4 years ]
    Baseline parameters predicting reduction of muscle and bone strength


Secondary Outcome Measures:
  • Relation of changes in predictors with reduced muscle and bone strength [ Time Frame: 4 years ]
    Relation of changes over time in predictors with reduced muscle and bone strength


Biospecimen Retention:   Samples Without DNA
Whole blood, plasma, serum and urine samples

Estimated Enrollment: 500
Actual Study Start Date: September 2016
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Outpatients clinics
Criteria

Inclusion Criteria:

  • Patients with type 1 or 2 diabetes

Exclusion Criteria:

  • Patients with any condition precluding mobility
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01600924


Contacts
Contact: Giuseppe Pugliese, MD, PhD +39 06 33775440 giuseppe.pugliese@uniroma1.it

Locations
Italy
University of Rome La Sapienza, Department of Clinical and Molecular Medicine, Sant'Andrea Hospital, Diabetes Unit Recruiting
Rome, RM, Italy, 00189
Contact: Laura Salvi, MD    +39 0633775249    adamas83@hotmail.it   
Sub-Investigator: Laura Salvi, MD         
Sponsors and Collaborators
Metabolic Fitness Association, Italy
University of Roma La Sapienza
Investigators
Study Director: Stefano Balducci, MD Sant'Andrea Hospital, Diabetes Unit
  More Information

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Giuseppe Pugliese, MD, PhD, Metabolic Fitness Association, Italy
ClinicalTrials.gov Identifier: NCT01600924     History of Changes
Other Study ID Numbers: MFA-12-02
First Submitted: May 16, 2012
First Posted: May 17, 2012
Last Update Posted: March 24, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Giuseppe Pugliese, Metabolic Fitness Association, Italy:
diabetes mellitus
muscle strength
bone strength
cardiovascular risk factors
diabetic complications

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases