Skip to content

Muscle Loss, Bone Weakness, and Trace Element Deficiencies in Pancreatic Diabetes, Their Prevalence, and Relationship with Blood Sugar Control

SPINE Study: Sarcopenia, Osteoporosis, and Trace Element Deficiencies in Pancreatogenic Diabetes Prevalence, Determinants, and Association with Glycemic Control - SPINE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/04/108665
Enrollment
55
Registered
2026-04-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M818- Other osteoporosis without currentpathological fracture Health Condition 2: E136- Other specified diabetes mellituswith other specified complications Health Condition 3: M628- Other specified disorders of muscle

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Intervention4: Nil: Nil Intervention5: Nil: Nil

Sponsors

Karnataka Endocrine Society
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Confirmed diagnosis of pancreatogenic diabetes Type 3c DM based on any one of the following Documented chronic pancreatitis on imaging including calcifications pancreatic atrophy or ductal changes OR Diabetes mellitus as per ADA criteria with diabetes developing after an episode of acute pancreatitis and evidence of persistent pancreatic damage Duration of diabetes 3 months or more Able and willing to provide written informed consent

Exclusion criteria

Exclusion criteria: Age 60 years or more excluded to limit the effect of age related sarcopenia and senile osteoporosis and to ensure uniformity of study data Type 1 diabetes or Type 2 diabetes without pancreatic disease C peptide or antibody testing if diagnostic uncertainty Pancreatic cancer active or within 5 years Recent pancreatic surgery within 6 months Acute pancreatitis within the preceding 6 weeks Severe liver disease Child Pugh class C cirrhosis Chronic kidney disease with eGFR less than 45 mL per minute per 1.73 m2 Known metabolic bone disease other than osteoporosis including osteomalacia and Paget disease Recent or current use of systemic glucocorticoids more than 5 mg prednisolone equivalent for more than 3 months Current use of bone active medications including bisphosphonates denosumab or teriparatide within the past 12 months Active malignancy with cachexia Pregnancy or lactation Unable to perform physical function tests including severe disability or bilateral lower limb amputation Current use of high dose mineral supplementation more than two times RDA for zinc magnesium copper or iron except vitamin D supplements Institutionalized patients

Design outcomes

Primary

MeasureTime frame
Prevalence of sarcopenia in pancreatogenic diabetes, assessed using AWGS 2019 criteria (handgrip strength, DXA-derived muscle mass, and physical performance), with classification into probable, confirmed, and severe sarcopenia.Timepoint: Single Cross Sectional Assessment at baseline

Secondary

MeasureTime frame
Secondary Outcomes Association of sarcopenia with HbA1c Association of osteoporosis with vitamin D levels and pancreatic disease duration Correlation of trace elements Zn Mg Cu Fe with ASMI BMD and HbA1c Exploratory Outcomes Osteosarcopenia defined as prevalence of concurrent sarcopenia and osteoporosis PERT adequacy defined as correlation of PERT use or dose with muscle bone and nutritional parametersTimepoint: Single Cross Sectional assessment at baseline

Countries

India

Contacts

Public ContactDr G Rachitha

Kasturba Medical College, Manipal

sahana.shetty@manipal.edu9900766492

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026