- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07626775
To Assess the Prevalence, Management Practices, and Clinical Outcomes Associated With Hyperglycemia Among Hospitalized Patients, With a Particular Focus on the Interplay Between Metabolic Biomarkers, Nutritional Status, and Body Composition (CLIOHA)
May 29, 2026 updated by: Surender ., Medanta, The Medicity, India
This was a prospective, observational cross-sectional study conducted at a tertiary care private hospital in India.
The study was designed to comprehensively evaluate the prevalence, management strategies, and clinical outcomes of in-hospital hyperglycemia among adult inpatients.
The study also explored the associations of metabolic biomarkers-fetuin-A and fibroblast growth factor-21 (FGF-21) as well as sarcopenic obesity and nutritional factors with clinical outcomes, including length of hospital stay (LOS), complications, and mortality.
Institutional Ethics Committee approval was obtained prior to study initiation, and written informed consent was secured from all participants
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
362
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Haryana
-
Gurgaon, Haryana, India, 122001
- Division Of Endocrinology & Diabetes
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Newly diagnosed type 2 diabetes mellitus (T2DM) or those presenting with hyperglycemia
Description
Inclusion Criteria:
- Adult patients aged ≥18 years.
- Patients with known or newly diagnosed type 2 diabetes mellitus (T2DM) or those presenting with hyperglycemia (random blood glucose ≥140 mg/dL) during hospitalization.
- Both medical and surgical inpatients admitted for ≥24 hours
Exclusion Criteria:
- Pregnant or lactating women.
- Patients with type 1 diabetes mellitus or other specific types of diabetes (e.g., pancreatogenic, drug-induced).
- Patients with chronic liver disease unrelated to diabetes or hepatic dysfunction secondary to viral hepatitis, autoimmune hepatitis, or alcohol abuse.
- Critically ill patients requiring palliative care or those with advanced malignancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To determine the prevalence of hyperglycemia
Time Frame: 10 Days
|
To determine the prevalence of hyperglycemia and pre-existing or newly diagnosed type 2 diabetes mellitus (T2DM) among hospitalized patients
|
10 Days
|
|
Assess clinical outcomes associated with hyperglycemia
Time Frame: 10 Days
|
To assess clinical outcomes associated with hyperglycemia, including in-hospital complications, mortality, need for critical care support, and length of hospital stay (LOS)
|
10 Days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of sarcopenic obesity
Time Frame: 10 Days
|
To assess the prevalence of sarcopenic obesity among diabetic and hyperglycemic patients, and to determine its association with metabolic dysfunction and adverse outcomes
|
10 Days
|
|
Analyze serum biomarker level fetuin-A
Time Frame: 10 Days
|
To analyze serum biomarker level fetuin-A and correlate them with severity of metabolic dysregulation .Serum fetuin-A levels were measured using commercially available enzyme-linked immunosorbent assay (ELISA) kits
|
10 Days
|
|
Analyze serum biomarker level FGF-21
Time Frame: 10 Days
|
To analyze serum biomarker levels FGF-21 and correlate them with severity of metabolic dysregulation.Serum FGF-21 levels were measured using commercially available enzyme-linked immunosorbent assay (ELISA) kits
|
10 Days
|
|
Analyze serum biomarker level FGF-21
Time Frame: 10 Days
|
To analyze serum biomarker levels FGF-21 and correlate them with liver fibrosis indices.Serum FGF-21 levels were measured using commercially available enzyme-linked immunosorbent assay (ELISA) kits
|
10 Days
|
|
Analyze serum biomarker level fetuin-A
Time Frame: 10 Days
|
To analyze serum biomarker level fetuin-A and correlate them with liver fibrosis indices .Serum fetuin-A levels were measured using commercially available enzyme-linked immunosorbent assay (ELISA) kits
|
10 Days
|
|
To assess Impact of diet
Time Frame: 10 Days
|
To assess the impact of adequacy of dietary on glycemic control and recovery, will measure the Sugar level at Before Breakfast,Before Lunch,Before Dinner
|
10 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bin Rakhis SA Sr, AlDuwayhis NM, Aleid N, AlBarrak AN, Aloraini AA. Glycemic Control for Type 2 Diabetes Mellitus Patients: A Systematic Review. Cureus. 2022 Jun 21;14(6):e26180. doi: 10.7759/cureus.26180. eCollection 2022 Jun.
- Wangnoo SK, Baruah MP, Lodha S, Sanyal D, Goyal R, Sooragonda BG, Chandrasekaran S, Vijay Kumar G. In-Hospital Management of Hyperglycemia: The Role of Insulin Degludec. Diabetes Ther. 2025 Apr;16(4):547-568. doi: 10.1007/s13300-025-01707-w. Epub 2025 Feb 27.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Actual)
February 1, 2026
Study Completion (Actual)
March 1, 2026
Study Registration Dates
First Submitted
May 14, 2026
First Submitted That Met QC Criteria
May 29, 2026
First Posted (Actual)
June 4, 2026
Study Record Updates
Last Update Posted (Actual)
June 4, 2026
Last Update Submitted That Met QC Criteria
May 29, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1521/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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