Skip to content

A study to find out how many patients suffers from Pancreatic Exocrine Insufficiency in Patients With Diabetes Mellitus in India

A Cross-sectional Study to Determine the Prevalence of Pancreatic Exocrine Insufficiency Among Patients With Diabetes Mellitus in India

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/09/021137
Enrollment
351
Registered
2019-09-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: K869- Disease of pancreas, unspecified

Interventions

Intervention1: NIL: NIL

Sponsors

Abbott India Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female patients >=18 years of age 2. Patients with duration of DM for at least 5 years 3. Patients willing to participate in the study by signing the Patient Authorization Form (PAF)

Exclusion criteria

Exclusion criteria: 1. Patients with known gastrointestinal conditions such as known/documented chronic pancreatitis, inflammatory bowel disease, Crohnâ??s disease etc. or other known causes of PEI 2. Patients already taking treatment with pancreatic enzyme replacement therapy (PERT) 3. Any condition that in the opinion of the investigator does not justify the patientâ??s inclusion in the study

Design outcomes

Primary

MeasureTime frame
Number and percentage of patients with DM diagnosed with PEI (based on PEI-Q, anthropometry, and FE-1 levels)Timepoint: At the end of study

Secondary

MeasureTime frame
1. Sociodemographic and clinical profile characteristics 2. Risk factors for PEI (based on PEI-Q, anthropometry, and FE-1 levels) 3. Relationship between HbA1c levels (HbA1c 7.0% and â?¥7.0%) and PEI severity based on PEI-Q total symptoms scores (severe PEI: score â?¥ 1.8, moderate PEI: score 1.4. to 1.8, and minimal or mild PEI: score 0.60 to 1.4)Timepoint: At the end of study

Countries

India

Contacts

Public ContactSneha Nair

Abbott India Ltd

srirupa.das@abbott.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026