A Study of the Relationship of Markers of Cellular Senescence to Skeletal Parameters in Type 2 Diabetes Mellitus

Overview

About this study

The purpose of this study is to test whether markers of cellular aging and the SASP are elevated in subjects with obesity and further increased in patients with obesity and Type 2 Diabetes Mellitus (T2DM) and to relate markers of cellular aging (senescence) and the SASP to skeletal parameters (DXA, HRpQCT, bone turnover markers) in each of these groups.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Able and willing to provide informed consent.
  • Postmenopausal women (FSH > 20 IU/L).
  • Aged 50-80 years old.
  • Lean control subjects:  BMI < 25, Hemoglobin A1c 
  • Obese, non-diabetic subjects:  BMI ≥ 30, Hemoglobin A1c 
  • Obese, T2DM subjects:  BMI ≥ 30, Hemoglobin A1c > 6.5% (for at least the past 5 years).

Exclusion Criteria:

  • Clinical significant abnormality in any of the screening laboratory studies (see below).
  • Presence of (documented clinical diagnosis of any of the following):
    • Significant liver or renal disease;
    • Malignancy (including myeloma);
    • Malabsorption (as defined by clinical diagnosis);
    • Hypoparathyroidism (as defined by clinical diagnosis);
    • Hyperparathyroidism (as defined by clinical diagnosis);
    • Acromegaly;
    • Cushing’s syndrome;
    • Hypopituitarism;
    • Severe chronic obstructive pulmonary disease;
    • History of cardiac failure;
    • Bleeding disorders or current use of therapeutic doses of anticoagulants other than aspirin.
  • Undergoing treatment with any medications that affect bone turnover, including the following:
    • corticosteroids > 3 months at any time (inhaled steroids acceptable unless used year-round);
    • anticonvulsant therapy for seizures (carbamazepine or phenytoin within the previous year);
    • pharmacological doses of:
      • thiazolidinediones;
      • thyroid hormone (causing decline of thyroid stimulating hormone below normal);
      • Bisphosphonates (within the past 3 years);
      • denosumab, estrogen therapy or treatment with a selective estrogen receptor modulator, or teriparatide (within the past year).
    • Any history of fracture prior to screening.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sundeep Khosla, M.D.

Open for enrollment

Contact information:

Amanda Tweed

(507)255-6663

Tweed.Amanda@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20471253

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