Type2diabetesNCT05939921
Effects of Metformin Therapy on Pancreatic and Hepatic Fat Content in Patients of Type 2 Diabetes Mellitus
A study testing Metformin in people with Type2diabetes, run by Diabetes Foundation, India at 1 site in India.
Trial summary
A sample size of 15 patients with T2DM visiting Fortis C DOC Hospital will be recruited with informed, written consent and will be requested to answer a validated questionnaire in a language known to them (English/Hindi). Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2diabetes
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2022to 30 Jun 2023
- Phase
- Interventional
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight \& obese (BMI 23.0 -35 kg/m2) subjects aged 30-60 years with T2DM of less than 5 year duration with HbA1c 6.5% to 9% \& on a stable dose of metformin and/or sulphonylureas over last 8 weeks, fatty liver on ultrasound.
Who cannot join
- The sample patient excluded in this study who had following medical history like: hypoglycaemia, diabetic abscess/ulcers, ketoacidosis, pregnant or lactating women, women planning for pregnancy/gestational diabetes, severe cardiac and renal disease, patients with renal transplant /undergoing immunosuppressive therapy for renal transplant ,substantial alcohol consumption, Child-Pugh B/C cirrhosis, other causes of liver disease, confounding concomitant drug use (including insulin, incretin mimetics, thiazolidinediones, vitamin E), and disorders such as a medical history of pancreatitis, pancreatic lipomatosis or pancreatic calculi (as detected by ultrasonography) ,type 1 diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Metformin Therapy on Pancreatic and Hepatic Fat Content Using 3.0 Tesla Magnetic Resonance Imaging Proton Density Fat Fraction Software in Patients of T2DM: Prospective Open Label Case Control 16 Weeks Proof of Concept Study
A sample size of 15 patients with T2DM visiting Fortis C DOC Hospital will be recruited with informed, written consent and will be requested to answer a validated questionnaire in a language known to them (English/Hindi). All these patients will undergo 2 weeks diet and exercise run in period using standard guidelines. Clinical details will be obtained from the case records of the patients. Anthropometry, skinfolds \& blood pressure will be recorded as mentioned in previous studies from our group (see below for details)18,19. Overweight and, obesity will be defined according to predefined guidelines for Asian Indians20. Abdominal obesity is defined as waist circumference of ≥ 90 centimetres (cms) in males and ≥ 80 cms in females21. Each eligible subject will undergo ultrasonography of liver and pancreas before recruitment. Following ultrasonography, patients fulfilling the inclusion will be randomised to receive the 10 mg of Dapagliflozin as mentioned previously. Biochemistry, ultrasonography, DEXA, MRI, will be performed at baseline and at 4 months post intervention.
Read the detailed description
A chronic metabolic disorder described by continuous hyperglycemia we call Diabetes mellitus or DM. this metabolic disorder could be for various reasons like resisting to marginal action of insulin, also could be due to diminished secretion of insulin, or maybe both. This Chronic hyperglycemia could be responsible for other kinds of abnormalities and therefore damage various organs in the patient, sometimes this also could even be life threatening complications.
NAFLD (Nonalcoholic fatty liver disease) has the highest incidence rate among obese and diabetic patients. In various studies, it has been found that Type 2 diabetes mellitus (T2DM) and nonalcoholic fatty liver disease (NAFLD) exist together which is a metabolic disorder. It has been found that the occurrence of NAFLD is 59.67% among T2DM patients with nonalcoholic steatohepatitis (NASH), simple steatosis (NAFL), and cirrhosis.
The studies reveal that NAFLD of 70% is usually found among T2DM patients. It is also observed that obesity and insulin resistance is correlated with NAFLD.
Noninvasive assessment and staging of disease are based on clinical parameters such as age, sex, liver function test, platelet count, lipid profile, BMI, and imaging modalities such as USG, Fibro-scan (FS), and magnetic resonance imaging mass spectroscopy. Such clinical scoring systems and TE are useful in the early detection of NAFLD and predicting fibrosis. The principle behind the management of NAFLD with T2DM involves an indirect effect through improvement in IR and glycemia and thus is used for the treatment of T2DM as well.
In addition to this, fatty pancreas is gaining importance from the research point of view. Study done by our group also showed that subcutaneous and intra-abdominal obesity, including fatty liver and pancreatic volume, were larger in non-obese Asian Indians with type 2 diabetes than in BMI-matched non-diabetic participants, whereas peripheral subcutaneous adiposity was lower. A study done in animal model shows that metformin exerted a beneficial effect in limiting beta-proliferation caused by high fat diet (HFD) fed to mice and also improved insulin resistance. Another study also showed similar effects of Metformin therapy, as it decreased the amount of fat in the liver in parallel with an improvement in the metabolic parameters and may, thus, be beneficial for preventing the late consequences of NAFLD in newly diagnosed diabetic patients.
The study mentioned below predicted that Metformin would considerably reduce pancreatic and liver fat in T2DM patients. Metformin does not appear to cause or exacerbate liver injury and, indeed, is often beneficial in patients with nonalcoholic fatty liver disease. Nonalcoholic fatty liver frequently presents with transaminase elevations but should not be considered a contraindication to metformin use. Literature evidence of liver disease being associated with metformin-associated metabolic acidosis is largely represented by case reports.
A recent study from Korea shows that in patients with type-2 diabetes mellitus, the mean FIB-4 score increased from 1.38 to 1.51 (p=0.001) after 2 years of metformin therapy, whereas the mean HSI score fell from 27.3 to 26.5 (p=0.001).
While these studies established that hepatic fat and pancreatic volume are high even in non-obese patients with T2DM, we were unable to estimate of hepatic and pancreatic fat precisely due to non-availability of advanced fat-imaging MRI software.
Review of Literature: Effects of SGLT2 Inhibitors and Abdominal Adipose Tissue Depots Metformin is an effective agent which helps to achieve better blood glucose control. This drug also benefits in the reduction of weight and blood pressure. Metformin results in weight loss.
Effect on Fat Mass:
Apart from weight loss, Metformin has been shown to reduce fat. It was reported that the use of Metformin significantly reduces body weight in T2DM patients on metformin therapy and inadequate glycemic control.
- Conditions
- Type2diabetes
- Being tested
- Metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
T2DM patients will be provided with metformin in a specified dose
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | T2DM patients will be provided with metformin in a specified dose Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of metformin on Pancreatic fat and hepatic fat in T2DM patients.
T2DM patients will undergo MRI, Ultrasound and Fibroscan testing to determine the level of fat in pancreas and liver.
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 May 2022
- Primary completion28 Feb 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2diabetesStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diabetes Foundation, India
- Sponsor type
- University, hospital or other
- Collaborators
- National Diabetes Obesity and Cholesterol Foundation
- Responsible party
- Principal investigator, Dr Anoop Misra, Diabetes Foundation, India
- Investigators
- Anoop Misra, MD, Principal investigator, Fortis CDOC Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939921
- Sponsor's protocol ID
- MET
- Status last verified
- Jul 2023
- First submitted
- 3 Jul 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Metformin Therapy on Pancreatic and Hepatic Fat Content Using 3.0 Tesla Magnetic Resonance Imaging Proton Density Fat Fraction Software in Patients of T2DM: Prospective Open Label Case Control 16 Weeks Proof of Concept Study
- ClinicalTrials.gov ID
- NCT05939921
- Acronym / sponsor ID
- MET
- Conditions
- Type2diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Diabetes Foundation, IndiaUniversity, hospital or other
- Collaborators
- National Diabetes Obesity and Cholesterol Foundation
- Study start
- 1 May 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 11 Jul 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.
A sample size of 15 patients with T2DM visiting Fortis C DOC Hospital will be recruited with informed, written consent and will be requested to answer a validated questionnaire in a language known to them (English/Hindi). All these patients will undergo 2 weeks diet and exercise run in period using standard guidelines. Clinical details will be obtained from the case records of the patients. Anthropometry, skinfolds \& blood pressure will be recorded as mentioned in previous studies from our group (see below for details)18,19. Overweight and, obesity will be defined according to predefined guidelines for Asian Indians20. Abdominal obesity is defined as waist circumference of ≥ 90 centimetres (cms) in males and ≥ 80 cms in females21. Each eligible subject will undergo ultrasonography of liver and pancreas before recruitment. Following ultrasonography, patients fulfilling the inclusion will be randomised to receive the 10 mg of Dapagliflozin as mentioned previously. Biochemistry, ultrasonography, DEXA, MRI, will be performed at baseline and at 4 months post intervention.
Detailed description
A chronic metabolic disorder described by continuous hyperglycemia we call Diabetes mellitus or DM. this metabolic disorder could be for various reasons like resisting to marginal action of insulin, also could be due to diminished secretion of insulin, or maybe both. This Chronic hyperglycemia could be responsible for other kinds of abnormalities and therefore damage various organs in the patient, sometimes this also could even be life threatening complications.
NAFLD (Nonalcoholic fatty liver disease) has the highest incidence rate among obese and diabetic patients. In various studies, it has been found that Type 2 diabetes mellitus (T2DM) and nonalcoholic fatty liver disease (NAFLD) exist together which is a metabolic disorder. It has been found that the occurrence of NAFLD is 59.67% among T2DM patients with nonalcoholic steatohepatitis (NASH), simple steatosis (NAFL), and cirrhosis.
The studies reveal that NAFLD of 70% is usually found among T2DM patients. It is also observed that obesity and insulin resistance is correlated with NAFLD.
Noninvasive assessment and staging of disease are based on clinical parameters such as age, sex, liver function test, platelet count, lipid profile, BMI, and imaging modalities such as USG, Fibro-scan (FS), and magnetic resonance imaging mass spectroscopy. Such clinical scoring systems and TE are useful in the early detection of NAFLD and predicting fibrosis. The principle behind the management of NAFLD with T2DM involves an indirect effect through improvement in IR and glycemia and thus is used for the treatment of T2DM as well.
In addition to this, fatty pancreas is gaining importance from the research point of view. Study done by our group also showed that subcutaneous and intra-abdominal obesity, including fatty liver and pancreatic volume, were larger in non-obese Asian Indians with type 2 diabetes than in BMI-matched non-diabetic participants, whereas peripheral subcutaneous adiposity was lower. A study done in animal model shows that metformin exerted a beneficial effect in limiting beta-proliferation caused by high fat diet (HFD) fed to mice and also improved insulin resistance. Another study also showed similar effects of Metformin therapy, as it decreased the amount of fat in the liver in parallel with an improvement in the metabolic parameters and may, thus, be beneficial for preventing the late consequences of NAFLD in newly diagnosed diabetic patients.
The study mentioned below predicted that Metformin would considerably reduce pancreatic and liver fat in T2DM patients. Metformin does not appear to cause or exacerbate liver injury and, indeed, is often beneficial in patients with nonalcoholic fatty liver disease. Nonalcoholic fatty liver frequently presents with transaminase elevations but should not be considered a contraindication to metformin use. Literature evidence of liver disease being associated with metformin-associated metabolic acidosis is largely represented by case reports.
A recent study from Korea shows that in patients with type-2 diabetes mellitus, the mean FIB-4 score increased from 1.38 to 1.51 (p=0.001) after 2 years of metformin therapy, whereas the mean HSI score fell from 27.3 to 26.5 (p=0.001).
While these studies established that hepatic fat and pancreatic volume are high even in non-obese patients with T2DM, we were unable to estimate of hepatic and pancreatic fat precisely due to non-availability of advanced fat-imaging MRI software.
Review of Literature: Effects of SGLT2 Inhibitors and Abdominal Adipose Tissue Depots Metformin is an effective agent which helps to achieve better blood glucose control. This drug also benefits in the reduction of weight and blood pressure. Metformin results in weight loss.
Effect on Fat Mass:
Apart from weight loss, Metformin has been shown to reduce fat. It was reported that the use of Metformin significantly reduces body weight in T2DM patients on metformin therapy and inadequate glycemic control.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: MetforminT2DM patients will be provided with metformin in a specified dose |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Overweight \& obese (BMI 23.0 -35 kg/m2) subjects aged 30-60 years with T2DM of less than 5 year duration with HbA1c 6.5% to 9% \& on a stable dose of metformin and/or sulphonylureas over last 8 weeks, fatty liver on ultrasound.
Key exclusion criteria (1 listed)
- The sample patient excluded in this study who had following medical history like: hypoglycaemia, diabetic abscess/ulcers, ketoacidosis, pregnant or lactating women, women planning for pregnancy/gestational diabetes, severe cardiac and renal disease, patients with renal transplant /undergoing immunosuppressive therapy for renal transplant ,substantial alcohol consumption, Child-Pugh B/C cirrhosis, other causes of liver disease, confounding concomitant drug use (including insulin, incretin mimetics, thiazolidinediones, vitamin E), and disorders such as a medical history of pancreatitis, pancreatic lipomatosis or pancreatic calculi (as detected by ultrasonography) ,type 1 diabetes mellitus.
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 |
|---|---|---|
| MetforminT2DM patients will be provided with metformin in a specified dose | Drug | Treatment |
Primary outcome
To assess the effect of metformin on Pancreatic fat and hepatic fat in T2DM patients.
Time frame: 120 days
T2DM patients will undergo MRI, Ultrasound and Fibroscan testing to determine the level of fat in pancreas and liver.
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 25 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Anoop Misra, MD principal investigator
Fortis CDOC Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin in people with Type2diabetes, run by Diabetes Foundation, 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 1 inclusion and 1 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 25 Jul 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.
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 the effect of metformin on Pancreatic fat and hepatic fat in T2DM patients. (time frame: 120 days). 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 25 Jul 2023.