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

NCT01600924 | Active Not Recruiting

• 1 other identifier: MFA-12-02
• Study Type: observational
• Target: 1,018
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Keywords

diabetes mellitus; muscle strength; bone strength; cardiovascular risk factors; diabetic complications

Outcome Measures

Primary Outcomes (1)

• Independent predictors of reduced muscle and bone strength

  Baseline parameters predicting reduction of muscle and bone strength

  4 years

Secondary Outcomes (1)

• Relation of changes in predictors with reduced muscle and bone strength

  4 years

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Outpatients clinics

You may qualify if:

• Patients with type 1 or 2 diabetes

You may not qualify if:

• Patients with any condition precluding mobility

Sponsors & Collaborators

• Metabolic Fitness Association, Italy: lead
• University of Roma La Sapienza: collaborator

Study Sites (1)

University of Rome La Sapienza, Department of Clinical and Molecular Medicine, Sant'Andrea Hospital, Diabetes Unit

Rome, RM, 00189, Italy

Location

Related Publications (10)

• Andreassen CS, Jakobsen J, Andersen H. Muscle weakness: a progressive late complication in diabetic distal symmetric polyneuropathy. Diabetes. 2006 Mar;55(3):806-12. doi: 10.2337/diabetes.55.03.06.db05-1237.

  PMID: 16505247 BACKGROUND

• Andreassen CS, Jakobsen J, Ringgaard S, Ejskjaer N, Andersen H. Accelerated atrophy of lower leg and foot muscles--a follow-up study of long-term diabetic polyneuropathy using magnetic resonance imaging (MRI). Diabetologia. 2009 Jun;52(6):1182-91. doi: 10.1007/s00125-009-1320-0. Epub 2009 Mar 12.

  PMID: 19280173 BACKGROUND

• Stenholm S, Harkanen T, Sainio P, Heliovaara M, Koskinen S. Long-term changes in handgrip strength in men and women--accounting the effect of right censoring due to death. J Gerontol A Biol Sci Med Sci. 2012 Oct;67(10):1068-74. doi: 10.1093/gerona/gls064. Epub 2012 Mar 15.

  PMID: 22421705 BACKGROUND

• IJzerman TH, Schaper NC, Melai T, Meijer K, Willems PJ, Savelberg HH. Lower extremity muscle strength is reduced in people with type 2 diabetes, with and without polyneuropathy, and is associated with impaired mobility and reduced quality of life. Diabetes Res Clin Pract. 2012 Mar;95(3):345-51. doi: 10.1016/j.diabres.2011.10.026. Epub 2011 Nov 21.

  PMID: 22104262 BACKGROUND

• Vestergaard P. Discrepancies in bone mineral density and fracture risk in patients with type 1 and type 2 diabetes--a meta-analysis. Osteoporos Int. 2007 Apr;18(4):427-44. doi: 10.1007/s00198-006-0253-4. Epub 2006 Oct 27.

  PMID: 17068657 BACKGROUND

• Merlotti D, Gennari L, Dotta F, Lauro D, Nuti R. Mechanisms of impaired bone strength in type 1 and 2 diabetes. Nutr Metab Cardiovasc Dis. 2010 Nov;20(9):683-90. doi: 10.1016/j.numecd.2010.07.008.

  PMID: 20934862 BACKGROUND

• Melton LJ 3rd, Leibson CL, Achenbach SJ, Therneau TM, Khosla S. Fracture risk in type 2 diabetes: update of a population-based study. J Bone Miner Res. 2008 Aug;23(8):1334-42. doi: 10.1359/jbmr.080323.

  PMID: 18348689 BACKGROUND

• Howe TE, Shea B, Dawson LJ, Downie F, Murray A, Ross C, Harbour RT, Caldwell LM, Creed G. Exercise for preventing and treating osteoporosis in postmenopausal women. Cochrane Database Syst Rev. 2011 Jul 6;2011(7):CD000333. doi: 10.1002/14651858.CD000333.pub2.

  PMID: 21735380 BACKGROUND

• Conti F, Balducci S, Pugliese L, D'Errico V, Vitale M, Alessi E, Salerno G, Iacobini C, Menini S, Bollanti L, Nicolucci A, Pugliese G. Correlates of Calcaneal Quantitative Ultrasound Parameters in Patients with Diabetes: The Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes. J Diabetes Res. 2017;2017:4749619. doi: 10.1155/2017/4749619. Epub 2017 Sep 19.

  PMID: 29057273 DERIVED

• Balducci S, Sacchetti M, Orlando G, Salvi L, Pugliese L, Salerno G, D'Errico V, Iacobini C, Conti FG, Zanuso S, Nicolucci A, Pugliese G; Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes SAMBA Investigators. Correlates of muscle strength in diabetes: The study on the assessment of determinants of muscle and bone strength abnormalities in diabetes (SAMBA). Nutr Metab Cardiovasc Dis. 2014 Jan;24(1):18-26. doi: 10.1016/j.numecd.2013.04.010. Epub 2013 Oct 3.

  PMID: 24095149 DERIVED

Related Links

• Study protocol

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, plasma, serum and urine samples

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes Mellitus; Diabetes Complications

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Stefano Balducci, MD

  Sant'Andrea Hospital, Diabetes Unit

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 16, 2012
• First Posted: May 17, 2012
• Study Start: September 1, 2016
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)