Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Progression and Etiology of Cortical Porosity in Diabetic Bone Disease (PREPT2D)

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.
 
ClinicalTrials.gov Identifier: NCT04208230
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
Type 2 diabetes is associated with increased cortical bone porosity and increased fracture risk. The goal of this proposed study is to understand the longitudinal evolution of cortical bone porosity and to investigate the underlying biological processes that drive increased cortical porosity and fracture risk in the setting of diabetes. The investigators will apply novel techniques for in vivo imaging of cortical pores to patients with type 2 diabetes and controls in a longitudinal prospective study. This work will establish the longitudinal progression of cortical porosity and determine whether pore content can serve as a predictor of future cortical degradation and bone fragility.

Condition or disease Intervention/treatment
Type 2 Diabetes Device: XtremeCT

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 96 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Progression and Etiology of Cortical Porosity in Diabetic Bone Disease
Actual Study Start Date : January 3, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Diseases

Group/Cohort Intervention/treatment
Subjects diagnosed with type 2 diabetes mellitus
Subjects with type 2 diabetes defined as those with (1) history and diagnosis of T2D and pharmacologic treatment for a minimum of 3 years OR (2) history and diagnosis of T2D with documented HgbA1C of 6.5 or higher for a minimum of 3 years if they are not under pharmacologic treatment (i.e., diet-controlled)
Device: XtremeCT
HRpQCT technology provides information on bone microarchitecture, bone density and bone strength by measuring the cortical and trabecular bone structures with improved spatial resolution and defining the surfaces in three-dimensional manner.
Other Name: High-resolution peripheral quantitative computed tomography (HRpQCT)

Control
Non-diabetic control group. These subjects must not have pre-diabetes.
Device: XtremeCT
HRpQCT technology provides information on bone microarchitecture, bone density and bone strength by measuring the cortical and trabecular bone structures with improved spatial resolution and defining the surfaces in three-dimensional manner.
Other Name: High-resolution peripheral quantitative computed tomography (HRpQCT)




Primary Outcome Measures :
  1. Amount of fat within cortical pores at the distal tibia at baseline [ Time Frame: Baseline ]
    The investigators will apply a combined HR-pQCT and MR pore content characterization technique to quantify the amount of fat within cortical pores at the distal tibia in T2D subjects and matched controls.

  2. Amount of vessels within cortical pores at the distal tibia at baseline. [ Time Frame: Baseline ]
    The investigators will apply a combined HRpQCT and MR pore content characterization technique to quantify the proportion of cortical pores containing vessels at the distal tibia at baseline in T2D subjects and matched controls. .

  3. Association between Type 2 diabetes status and marrow fat at the distal tibia [ Time Frame: Baseline and 24 months ]
    Cortical porosity at the distal tibia will be assessed by HRpQCT at baseline and 24 months in T2D subjects and matched controls.


Biospecimen Retention:   Samples Without DNA
Serum will be frozen for future batch analysis of 1.25(OH)2D, sclerostin, the fat-secreted hormones (adipokines), adiponectin and leptin, estradiol, angiogenesis markers vascular endothelial growth factor (VEGF), angiopoiten-1 and antagonist ang-2, and the bone turnover markers C-terminal cross-linkingtelopeptide of type I collagen (CTX; bone resorption), total aminoterminal propeptide of type I collagen (PINP; bone formation), and bone-specific alkaline phosphatase (BAP; bone formation). Serum and urine will be stored for possible future analyses.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects with type 2 diabetes will be recruited from primary care clinics all over San Francisco;
Criteria

Inclusion Criteria:

  • Postmenopausal female and/or male
  • 50-70 years old
  • Body mass index (BMI) of 18-40
  • Subjects with bone mineral density of: 0 ≥ T-score > -2.5
  • Additional requirement for type II diabetes patients:

    • Patients has a history of type II diabetes, as defined by the American Diabetes Association for more than 3 years. Patients must either have a documented HbA1C of 6.5 or higher for 3 or more years if they are not undergoing pharmacological treatment (diet controlled), or must have been receiving pharmacological treatment for the past 3 years.

Exclusion Criteria:

  • Perimenopausal women, defined as last menses within previous 3 years
  • History of metabolic bone disease other than post-menopausal bone loss. Persons with the following diseases: chronic gastrointestinal disease (including inflammatory bowel disease, celiac disease, or other malabsorptive disease including short-gut syndrome), renal or hepatic impairment (known cirrhosis or if transaminase levels 3 times the upper limit of normal)
  • Current alcohol consumption (>3 alcohol drinks/day), current illicit drug use.
  • Use of medications known to impact bone and mineral metabolism, including use of a bisphosphonate or teriparatide in the last year or for >12 months ever, current calcitonin, prednisone > 5mg daily or the equivalent glucocorticoid for > 10 days in the last 3 months, current thiazolidinedione (TZD), thyroid hormone replacement with current thyroid stimulating hormone < 0.1 mIU/L. Patients undergoing hormone/testosterone replacement will NOT be excluded meaning they can be enrolled)
  • Trauma or surgery near radius or tibia imaging sites
  • An episode of immobilization lasting longer than 1 week in the previous 6 months
  • Estimated Glomerular Filtration Rate (eGFR)< 50 mL/min/1.73 m2 (baseline) or < 40 (follow-up). The investigators will require eGFR ≥ 50 at baseline in an effort to avoid the possibility of an enrolled subject dropping below the established safety level of 40 at follow-up. This was determined knowing that eGFR can decline at a rate of approximately 4.0 per year in diabetics (much lower in non-diabetics).
  • Conditions excluded by x-ray or MRI safety guidelines
  • Body mass index greater than 40 as these subjects will be too large to fit into the gantry of the MR scanner or exceed weight limitations of the MR table

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): NCT04208230


Contacts
Layout table for location contacts
Contact: Galateia Kazakia, PhD 415-353-4534 Galateia.Kazakia@ucsf.edu
Contact: Thelma Munoz 415-353-9454 Thelma.Munoz@ucsf.edu

Locations
Layout table for location information
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94197
Contact: Thelma Munoz    415-353-9454    Thelma.Munoz@ucsf.edu   
Principal Investigator: Galateia Kazakia, PhD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Layout table for investigator information
Principal Investigator: Galateia Kazakia, PhD University of California, San Francisco
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04208230    
Other Study ID Numbers: iRIS 16-20196
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Bone Diseases
Musculoskeletal Diseases