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Exploring metabolic proteins in key signaling pathways in Type 2 diabetes

A Cross-Sectional Study to Explore Metabolic Proteins in the PI3K/AKT and cAMP/PKA Signaling Pathways in Type 2 Diabetes Mellitus Patients. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/11/097305
Enrollment
252
Registered
2025-11-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: E11- Type 2 diabetes mellitus

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: NIL: This is an observational, cross-sectional study. No intervention or treatment was administered. Blood samples were collected from pa

Sponsors

Prof Nilanjan Saha
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy Controls Age between 18 and 65 years Both Male and Female HbA1c less than 5.7 percent based on ADA diagnostic criteria for normal glucose tolerance. No history of acute or chronic infections, inflammatory diseases, or malignancy. Not currently taking medications known to affect glucose metabolism, lipid profile, or inflammatory markers. Willing to provide written informed consent Pre-diabetes Age between 18 and 65 years Both Male and female HbA1c between 5.7 and 6.4 percent No prior diagnosis of diabetes mellitus No ongoing antidiabetic treatment Free from chronic illnesses such as renal, hepatic, cardiac, or autoimmune diseases. Willing to provide written informed consent T2DM Age between 18 and 65 years Both Male and female HbA1c equal to or more than 6.5 percent as per ADA criteria or patient taking OHAs Stable clinical condition without history of diabetic ketoacidosis, hyperosmolar hyperglycemic state, or recent hospitalization (within last 3 months). Not on medications that could affect study biomarkers, except for prescribed antidiabetic drugs and routine medications for controlled comorbidities. Participants willing to provide written informed consent and adhere to study protocols.

Exclusion criteria

Exclusion criteria: Age below 18 years or above 65 years Pregnant or lactating women History of type 1 diabetes, gestational diabetes, or secondary diabetes Presence of chronic systemic illness (renal failure, advanced liver disease, heart failure, autoimmune disorders, malignancy) Acute infection or hospitalization in last three months Current use of medicines that significantly alter glucose metabolism, lipid profile, or inflammatory markers (other than prescribed oral antidiabetic drugs) Inability or unwillingness to provide informed consent

Design outcomes

Primary

MeasureTime frame
Serum levels of GP73, FAM3A, ASGR1, and GPHB5 measured by ELISA in Healthy, Prediabetes, and Type 2 Diabetes Mellitus groups. Correlation of serum GP73, FAM3A, ASGR1, and GPHB5 with key glycemic parameters (HbA1c, fasting plasma glucose). Timepoint: There will be a single assessment at baseline (at the time of enrollment)

Secondary

MeasureTime frame
Association of serum GP73, FAM3A, ASGR1, & GPHB5 with inflammatory markers (IL-1B, IL-10). Comparison of biomarker levels (GP73, FAM3A, ASGR1, GPHB5) across demographic subgroups (age, sex, BMI).Timepoint: The assessment will be conducted only once at baseline.

Countries

India

Contacts

Public ContactZoya Khan

Jamia Hamdard

zoyalam02@gmail.com7518007282

Outcome results

None listed

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