Pancreatic LipomatosisPhase 4NCT05797935
Evaluation of Changes in Pancreatic Fat Content Using Advanced MR Sequences in Diabetics on Dapagliflozin Therapy
A Phase 4 study testing Dapagliflozin 10mg Tab in people with Pancreatic Lipomatosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
The study aimed to assess changes in pancreatic fat content in people with diabetes on dapagliflozin (SGLT2 inhibitor) and beta cell function. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pancreatic Lipomatosis
- What is being tested?
- Dapagliflozin 10mg Tab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2021to 31 Dec 2022
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years,
- Hba1c 7-11%,
- Renal function (MDRD) > 30 ml/min, on glucose-lowering therapy {metformin, sulfonylureas, glinides, dipeptidyl peptidase-4 (DPP-4) inhibitors, or basal insulin} at a stable dose for at least 3 months.
Who cannot join
- Uncontrolled hyperglycemia at screening (fasting blood glucose FBG ≥ 240 mg/dL).
- Diabetes other than type 2 diabetes
- Age younger than 18 years.
- Pregnant patients or lactating.
- Patients who refuse to give consent to be enrolled in the study.
- Any contraindication to magnetic resonance imaging.
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- More than 5% total body weight loss within the last month.
- Patients with moderate or severe renal impairment
- Any contraindication to SGLT2i
- Prior SGLT2i within the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
The study aimed to assess changes in pancreatic fat content in people with diabetes on dapagliflozin (SGLT2 inhibitor) and beta cell function.
Read the detailed description
The study assessed and estimated the difference in pancreatic fat content in the patients of Type 2 Diabetes Mellitus at baseline and after taking dapagliflozin for 24 weeks.
The investigators even estimated the correlation between two advanced MR techniques commonly used for quantification of pancreatic fat (PDFF and MR Spectroscopy)
- Conditions
- Pancreatic Lipomatosis
- Being tested
- Dapagliflozin 10mg Tab
- Keywords
- Dapagliflozin, Pancreatic fat, MRI, Diabetes, MRS
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mg TabDrug
Dapagliflozin was given at a dose of 10 mg/day in one group and its effect was observed on the pancreatic fat content
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | No intervention | Only the standard drugs for type 2 diabetes were given. Dapagliflozin was not given in this group. |
| Dapagliflozin group | Active comparator | The patients were given standard drugs for type 2 diabetes and Dapagliflozin. Receives: Drug: Dapagliflozin 10mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess and estimate the difference in pancreatic fat content in the patients of Type 2 Diabetes Mellitus at baseline and after taking dapagliflozin for 24 weeks
The pancreatic fat percentage will be measured by MRI sequences at baseline and at 24 weeks and a change will be compared
Measured: 24 weeks
Secondary outcomes (1)
To estimate the correlation between two advanced MR techniques commonly used for quantification of pancreatic fat(PDFF and MR Spectroscopy)
The pancreatic fat percentage will be measured by MRI sequences at baseline and at 24 weeks and a correlation will be assessed
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start1 Aug 2021
- Primary completion20 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic LipomatosisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Control Trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashu Rastogi, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797935
- Sponsor's protocol ID
- 9805821254
- Status last verified
- Apr 2023
- First submitted
- 22 Mar 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Changes in Pancreatic Fat Content Using Advanced MR Sequences in Diabetics on Dapagliflozin Therapy
- ClinicalTrials.gov ID
- NCT05797935
- Acronym / sponsor ID
- 9805821254
- Conditions
- Pancreatic Lipomatosis
- Keywords
- Dapagliflozin, Pancreatic fat, MRI, Diabetes, MRS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 4 Apr 2023 (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.
The study aimed to assess changes in pancreatic fat content in people with diabetes on dapagliflozin (SGLT2 inhibitor) and beta cell function.
Detailed description
The study assessed and estimated the difference in pancreatic fat content in the patients of Type 2 Diabetes Mellitus at baseline and after taking dapagliflozin for 24 weeks.
The investigators even estimated the correlation between two advanced MR techniques commonly used for quantification of pancreatic fat (PDFF and MR Spectroscopy)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomised Control Trial
| Arm | Type | Receives |
|---|---|---|
| Placebo group | No intervention | –Only the standard drugs for type 2 diabetes were given. Dapagliflozin was not given in this group. |
| Dapagliflozin group | Active comparator | Drug: Dapagliflozin 10mg TabThe patients were given standard drugs for type 2 diabetes and Dapagliflozin. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years,
- Hba1c 7-11%,
- Renal function (MDRD) > 30 ml/min, on glucose-lowering therapy {metformin, sulfonylureas, glinides, dipeptidyl peptidase-4 (DPP-4) inhibitors, or basal insulin} at a stable dose for at least 3 months.
Key exclusion criteria (10 listed)
- Uncontrolled hyperglycemia at screening (fasting blood glucose FBG ≥ 240 mg/dL).
- Diabetes other than type 2 diabetes
- Age younger than 18 years.
- Pregnant patients or lactating.
- Patients who refuse to give consent to be enrolled in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10mg TabDapagliflozin was given at a dose of 10 mg/day in one group and its effect was observed on the pancreatic fat content | Drug | Dapagliflozin group |
Primary outcome
To assess and estimate the difference in pancreatic fat content in the patients of Type 2 Diabetes Mellitus at baseline and after taking dapagliflozin for 24 weeks
Time frame: 24 weeks
The pancreatic fat percentage will be measured by MRI sequences at baseline and at 24 weeks and a change will be compared
1 secondary outcome
To estimate the correlation between two advanced MR techniques commonly used for quantification of pancreatic fat(PDFF and MR Spectroscopy)
Time frame: 24 weeks
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 10 Apr 2023.
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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?
A Phase 4 study testing Dapagliflozin 10mg Tab in people with Pancreatic Lipomatosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh 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 10 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 10 Apr 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 assess and estimate the difference in pancreatic fat content in the patients of Type 2 Diabetes Mellitus at baseline and after taking dapagliflozin for 24 weeks (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2023.