Diabetes Mellitus, Type 2, Osteoporosis, Postmenopausal
Conditions
Brief summary
This study will help determine the effect of Glucagon Like Peptide-1 (GLP-1)receptor agonists on bone strength in postmenopausal women with type 2 diabetes mellitus (T2DM)
Detailed description
Postmenopausal women with diabetes mellitus have a higher risk of osteoporotic fractures, with significant associated mortality and morbidity. Osteoporosis is underdiagnosed in diabetes, as the bone mineral density (BMD) as currently measured is often normal despite underlying abnormalities. The trabecular bone score (TBS) is a novel modality to assess bone microarchitecture and accurately assess fracture risk in patients with diabetes. Due to increased co-prevalence of osteoporosis and diabetes mellitus, the potential effects of antidiabetic medications on fracture risk assume importance. Based on findings in animal studies, we hypothesize that GLP-1 receptor agonists increase TBS in postmenopausal women with (T2DM). The investigators propose a prospective non-randomized study by enrolling 48 patients (24 in the GLP-1 group and 24 in the non-GLP group). Dual-energy X-ray Absorptiometry (DXA )scans, markers of bone formation, and resorption, and selected inflammatory markers will be assessed at baseline, six months, and one year.
Interventions
DRUGGLP-1 receptor agonist
Diabetes medication
Sponsors
University of Mississippi Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Type 2 Diabetes Mellitus * Postmenopausal female * Age \>55 years * Hemoglobin A1c between 7-10% within 6 months of the first visit.
Exclusion criteria
* Patients with type 1 Diabetes mellitus * Patients with a history of GLP-1 receptor agonist/DPP4 inhibitor use * eGFR \<30 ml/min in the last 3 months * Patients with a history of pancreatitis * Personal or family history of medullary thyroid cancer * Patients with a history of treatment with anti-osteoporosis agents * Documented secondary osteoporosis * Documented presence of prosthesis or devices in the spine * Unwilling or unable to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trabecular Bone Score | 12 months after index date | The change in TBS from baseline to six months and one year after the initiation of a GLP-1 receptor agonist. TBS will be assessed by DXA scans done at baseline, six months and one year. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Markers and Bone Resorption Markers | 12 months after index date | The change in inflammatory markers (IL-1, IL-6 and TNF-alpha) and bone resorption markers (C-telopeptide) at 6 and 12 months after starting GLP-1 receptor agonists as compared to baseline. |
| Visceral Fat Mass | 12 months after index date | The change in visceral fat mass (measured by DXA) at 6 and 1 year after starting GLP-1 receptor agonists as compared to baseline. |
| Sclerostin and Bone Formation Markers | 12 months after index date | The change in levels of sclerostin, osteocalcin, and P1NP (as measured by commercial assays) from baseline to six months and one year after starting GLP-1 receptor agonist. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GLP-1 Cohort Participants on GLP-1 receptor agonists
GLP-1 receptor agonist: Diabetes medication | 3 |
| Non GLP-1 Cohort Participants not on GLP-1 receptor agonists | 2 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
Baseline characteristics
| Characteristic | Non GLP-1 Cohort | Total | GLP-1 Cohort |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 4 Participants | 3 Participants |
| Age, Continuous | 60 years | 58 years | 58 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 2 participants | 5 participants | 3 participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 2 |
| other Total, other adverse events | 0 / 3 | 0 / 2 |
| serious Total, serious adverse events | 0 / 3 | 0 / 2 |
Outcome results
Primary
Trabecular Bone Score
The change in TBS from baseline to six months and one year after the initiation of a GLP-1 receptor agonist. TBS will be assessed by DXA scans done at baseline, six months and one year.
Time frame: 12 months after index date
Population: Unfortunately at the time of enrollment the dexa scan was not functioning, after the machine was fixed we tried several times to contact the participants but could not get in touch with them. Therefore no dexa scans were done on the participants so no data was captured.
Secondary
Inflammatory Markers and Bone Resorption Markers
The change in inflammatory markers (IL-1, IL-6 and TNF-alpha) and bone resorption markers (C-telopeptide) at 6 and 12 months after starting GLP-1 receptor agonists as compared to baseline.
Time frame: 12 months after index date
Population: Despite several attempts to get in touch with participants we could not get in touch with them therefore no data to report.
Secondary
Sclerostin and Bone Formation Markers
The change in levels of sclerostin, osteocalcin, and P1NP (as measured by commercial assays) from baseline to six months and one year after starting GLP-1 receptor agonist.
Time frame: 12 months after index date
Secondary
Visceral Fat Mass
The change in visceral fat mass (measured by DXA) at 6 and 1 year after starting GLP-1 receptor agonists as compared to baseline.
Time frame: 12 months after index date
Population: Despite several attempts to get in touch with participants we could not get in touch with them therefore no data to report.