Diabete MellitusCLIOHANCT07626775
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
An observational study of Diabete Mellitus and Diabete Type 2, run by Medanta, The Medicity, India at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabete Mellitus, Diabete Type 2, Hyperglycaemia (Diabetic)
- How many people
- 362 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2023to 1 Mar 2026
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed type 2 diabetes mellitus (T2DM) or those presenting with hyperglycemia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Diabete Mellitus, Diabete Type 2, Hyperglycaemia (Diabetic)
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Hyperglycemia
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the prevalence of hyperglycemia
To determine the prevalence of hyperglycemia and pre-existing or newly diagnosed type 2 diabetes mellitus (T2DM) among hospitalized patients
Measured: 10 Days
Assess clinical outcomes associated with hyperglycemia
To assess clinical outcomes associated with hyperglycemia, including in-hospital complications, mortality, need for critical care support, and length of hospital stay (LOS)
Measured: 10 Days
Secondary outcomes (6)
Prevalence of sarcopenic obesity
To assess the prevalence of sarcopenic obesity among diabetic and hyperglycemic patients, and to determine its association with metabolic dysfunction and adverse outcomes
Measured: 10 Days
Analyze serum biomarker level fetuin-A
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
Measured: 10 Days
Analyze serum biomarker level FGF-21
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
Measured: 10 Days
Analyze serum biomarker level FGF-21
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
Measured: 10 Days
Analyze serum biomarker level fetuin-A
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
Measured: 10 Days
To assess Impact of diet
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
Measured: 10 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Jan 2023
- Primary completion1 Feb 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabete MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 362 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Medanta, The Medicity, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Surender ., Medanta, The Medicity, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626775
- Sponsor's protocol ID
- 1521/2023
- Acronym
- CLIOHA
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35891859Wangnoo 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.
PubMed 40014293
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07626775
- Acronym / sponsor ID
- CLIOHA / 1521/2023
- Conditions
- Diabete Mellitus, Diabete Type 2, Hyperglycaemia (Diabetic)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Medanta, The Medicity, IndiaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed type 2 diabetes mellitus (T2DM) or those presenting with hyperglycemia
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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)
6 secondary outcomes
Prevalence of sarcopenic obesity
Time frame: 10 Days
Analyze serum biomarker level fetuin-A
Time frame: 10 Days
Analyze serum biomarker level FGF-21
Time frame: 10 Days
Analyze serum biomarker level FGF-21
Time frame: 10 Days
Analyze serum biomarker level fetuin-A
Time frame: 10 Days
To assess Impact of diet
Time frame: 10 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Background: PubMed 35891859Bin 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.
- Background: PubMed 40014293Wangnoo 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabete Mellitus and Diabete Type 2, run by Medanta, The Medicity, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the prevalence of hyperglycemia (time frame: 10 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07626775, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.