Type 2 Diabetes MellitusNCT03223129
Insulin Sensitivity and Metabolomics During Oral Administration of Glucose and Graded Intravenous Infusion
A study testing Oral glucose tolerance test and Graded intravenous glucose infusion in people with Type 2 Diabetes Mellitus, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Bariatric surgery has been proven to be an effective treatment of type 2 diabetes and it has highlighted to role of the small intestine in glucose homeostasis. Improvement of glucose homeostasis occurs just a few days after the bariatric surgery, where parts of the small intestine is bypassed, has been performed. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Oral glucose tolerance test and Graded intravenous glucose infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jan 2018to 31 Jan 2019
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20 and 65
- BMI between 35 and 60 kg/m2
- Ability to understand and comply with the study process.
Who cannot join
- History of type 1 diabetes or secondary diabetes;
- Previous bariatric surgery;
- History of medical problems such as mental impairment;
- Major cardiovascular disease;
- Major gastrointestinal disease;
- Major respiratory disease;
Show all 12Show fewer
- Hormonal disorders;
- Infection;
- History of drug addiction and/or alcohol abuse;
- Internal malignancy;
- Pregnancy;
- Suspected or confirmed poor compliance;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Insulin Sensitivity and Metabolomics During Oral Administration of Glucose and a Graded Intravenous Infusion in Patients With Normal Glucose Tolerance, Impaired Glucose Tolerance and in Patients With Type 2 Diabetes Mellitus
Bariatric surgery has been proven to be an effective treatment of type 2 diabetes and it has highlighted to role of the small intestine in glucose homeostasis. Improvement of glucose homeostasis occurs just a few days after the bariatric surgery, where parts of the small intestine is bypassed, has been performed. Furthermore, conditioned medium from the duodenum and the jejunum from both diabetic rodents and humans are able to induce insulin resistance in normal mice and in myocytes. Hence the hypothesis is that the small intestine secretes factors that are able to induce insulin resistance.
This project aims to study how orally ingested glucose is able to induce insulin resistance and if this response differs in patients with normal glucose tolerance, impaired glucose tolerance and in patients with type 2 diabetes mellitus. To address this question glucose homeostasis will be studied by comparing whole body glucose uptake during a progressively increased oral glucose load with a graded glucose infusion where the blood glucose levels will be kept in the same range as during the oral glucose load in patients with normal glucose tolerance, impaired glucose tolerance and patients with type 2 diabetes mellitus.
Read more
Previous studied have shown that different metabolites and bile acids could be involved the regulation of glucose homeostasis. Hence, it is possible that the gut regulates metabolites that could be involved in small intestine-induced insulin resistance described above. The aim of this research is to study metabolomics in plasma collected during the oral glucose tolerance test with increasing load of glucose and the graded glucose infusion where plasma glucose level will be held in the same levels as during the oral glucose tolerance test and study the differences in patients with normal glucose tolerance, impaired glucose tolerance and in patients with type 2 diabetes mellitus.
The expected results in this study will demonstrate that the gut plays an important role in glucose homeostasis and that this system is dysregulated in type 2 diabetes. More importantly, novel factors derived or regulated from the gut that regulate insulin resistance and glucose tolerance will be identified which could be possible targets for future antidiabetic therapies.
Read the detailed description
The incidence of obesity and obesity-associated metabolic disorders such as insulin resistance and type 2 diabetes is increasing worldwide. To date, bariatric surgery is the only obesity treatment that results in long-term weight reduction. In addition, bariatric surgery has been reported to promote remission of type 2 diabetes and to be a more effective treatment than standard medication for type 2 diabetes. Surprisingly, improvement in glucose homeostasis after some bariatric surgery procedures occurs before weight loss is achieved. The mechanisms behind this improvement are still unclear but a recent study indicates that the bypassing of jejunum could play an important role in glucose homeostasis. Moreover, jejunum-derived proteins present in serum in both human and mice induce insulin resistance in cell cultures of myocytes and in mice. This taken together indicates that the gut may play an important role in glucose homeostasis in type 2 diabetes mellitus.
Metabolomics has recently been regarded to be one of the most suitable technologies for investigating complex diseases such as type 2 diabetes mellitus because it represent a real-time functional portrait of the organisms. Previous studies have shown that different metabolites and bile acids could be involved in the regulation of glucose homeostasis. Hence it is possible that the gut regulates metabolites that could be involved in the impaired glucose tolerance and type 2 diabetes mellitus.
The specific aims of this research project are:
Aim 1: To demonstrate that orally ingested glucose induces insulin resistance and to determine if this regulation of glucose homeostasis differs between subjects with normal glucose tolerance, impaired glucose tolerance and subjects with type 2 diabetes mellitus.
Aim 2: To identify metabolites regulated by the gut that are associated with impaired glucose tolerance and type 2 diabetes mellitus.
To address this aim, differences in glucose kinetics will be studied when glucose is orally administrated (in an oral glucose tolerance test, OGTT) compared to an graded intravenous glucose infusion, were plasma glucose levels are held in the same range as during the OGTT, in subjects with normal glucose tolerance (n = 8), impaired glucose tolerance (n = 8) and type 2 diabetes mellitus (n = 8).
Basal glucose kinetics will first be assessed by double glucose tracer technique. In the basal part of the glucose tolerance tests glucose tracer nr 1 will be infused and then be followed by either a continued infusion and a gradually increasing oral glucose load (25 g, 75 g and 125 g with a 2 h interval during the OGTT) with glucose tracer nr 2 or an graded intravenous glucose tracer infusion where plasma glucose levels are adjusted to those obtained during the OGTTs.
Gas chromatography/mass spectrometry will be used to measure isotopic enrichment of glucose tracers. Insulin, glucagon, total glucagon-like peptide 1 (GLP-1) and C-peptide will be measured by radioimmunoassays repeatedly during the glucose tolerance tests. Glucose kinetics including endogenous glucose production, insulin sensitivity and insulin secretion will be calculated. Differences in glucose kinetics between the oral and intravenous administration of glucose will be calculated and compared in subjects with normal glucose tolerance, impaired glucose tolerance or type 2 diabetes mellitus.
Analysis of metabolomics will be performed in plasma collected during the OGTT and the graded intravenous glucose infusion. Metabolites in plasma samples will be analyzed using two global profiling analytical platforms and a targeted profiling platform. Two-dimensional gas chromatography coupled to time-of-flight mass spectrometry (GCxGC-TOFMS) will be performed to measure small polar metabolites. Molecular lipids will be assessed by a global platform using ultra performance liquid chromatography coupled to quadrupole-TOFMS (UPLC-QTOFMS). A targeted platform based on UPLC coupled to triple-quadrupole MS (UPLC-QqQMS) will be performed to quantify both unconjugated and conjugated forms of bile acids.
Differences in plasma metabolites during OGTT and graded intravenous glucose infusion will be studied to assess information on possible regulation by the gut and the results will be compared in subjects with normal glucose tolerance, impaired glucose tolerance and subjects with type 2 diabetes mellitus.
Significance The expected results in this study will demonstrate that the gut plays an important role in glucose homeostasis and that this system is dysregulated in type 2 diabetes. More importantly, novel factors derived or regulated from the gut that regulate insulin resistance and glucose tolerance will be identified which could be possible targets for future antidiabetic therapies.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Oral glucose tolerance test, Graded intravenous glucose infusion
- Keywords
- Type 2 Diabetes Mellitus, Impaired glucose tolerance, Metabolomics
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose tolerance testOther
Oral glucose tolerance tests were glucose is administrated orally with an increasing load (25g, 75g, 100 g)
Graded intravenous glucose infusionOther
Graded intravenous glucose infusion where glucose is infused in order to receive an plasma glucose pattern comparable to those received during the oral glucose tolerance tests.
| Study group | Role | What they receive |
|---|---|---|
| Patients with normal glucose tolerance | Other | Patients included in this arm will have a plasma glucose below 140 mg/dl after a 2 h oral glucose tolerance test with a glucose load of 75 g.
All patients in this arm will undergo oral glucose tolerance test with increasing glucose load and a graded intravenous glucose infusion were plasma glucose levels are held at the same level as during the oral glucose tolerance test. Receives: Other: Oral glucose tolerance test; Other: Graded intravenous glucose infusion |
| Patients with impaired glucose tolerance | Other | Patients included in this arm will have a plasma glucose between 140 mg/dl to 199 mg/dl after a 2 h oral glucose tolerance test with a glucose load of 75 g.
All patients in this arm will undergo oral glucose tolerance test with increasing glucose load and a graded intravenous glucose infusion were plasma glucose levels are held at the same level as during the oral glucose tolerance test. Receives: Other: Oral glucose tolerance test; Other: Graded intravenous glucose infusion |
| Patients with type 2 diabetes mellitus | Other | Patients included in this arm will have a plasma glucose above 200 mg/dl after a 2 h oral glucose tolerance test with a glucose load of 75 g.
All patients in this arm will undergo oral glucose tolerance test with increasing glucose load and a graded intravenous glucose infusion were plasma glucose levels are held at the same level as during the oral glucose tolerance test. Receives: Other: Oral glucose tolerance test; Other: Graded intravenous glucose infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose kinetics
Whole body glucose uptake will be measured using a double glucose tracer technique during both the oral glucose tolerance test and the graded intravenous glucose infusion.
Measured: 1 year
Secondary outcomes (1)
Metabolomics
Plasma levels of small polar metabolites, molecular lipids and conjugated and unconjugated bile acids will be measured during both oral glucose tolerance test and during the graded intravenous glucose infusion.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start9 Jan 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients with either normal glucose tolerance, impaired glucose tolerance or with diagnosed type 2 diabetes mellitus will undergo oral glucose tolerance tests with an increasing load of glucose and thereafter isoglycemic intravenous glucose infusion.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen
- Responsible party
- Principal investigator, Geltrude Mingrone, Catholic University of the Sacred Heart
- Investigators
- Geltrude Mingrone, MD PhD, Principal investigator, The Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223129
- Sponsor's protocol ID
- U911/14
- Status last verified
- Jul 2019
- First submitted
- 12 Jun 2017
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mingrone G, Panunzi S, De Gaetano A, Ahlin S, Spuntarelli V, Bondia-Pons I, Barbieri C, Capristo E, Gastaldelli A, Nolan JJ. Insulin sensitivity depends on the route of glucose administration. Diabetologia. 2020 Jul;63(7):1382-1395. doi: 10.1007/s00125-020-05157-w. Epub 2020 May 8.
PubMed 32385603
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Sensitivity and Metabolomics During Oral Administration of Glucose and a Graded Intravenous Infusion in Patients With Normal Glucose Tolerance, Impaired Glucose Tolerance and in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03223129
- Acronym / sponsor ID
- U911/14
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Impaired glucose tolerance, Metabolomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 19 Jul 2017 (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.
Bariatric surgery has been proven to be an effective treatment of type 2 diabetes and it has highlighted to role of the small intestine in glucose homeostasis. Improvement of glucose homeostasis occurs just a few days after the bariatric surgery, where parts of the small intestine is bypassed, has been performed. Furthermore, conditioned medium from the duodenum and the jejunum from both diabetic rodents and humans are able to induce insulin resistance in normal mice and in myocytes. Hence the hypothesis is that the small intestine secretes factors that are able to induce insulin resistance.
This project aims to study how orally ingested glucose is able to induce insulin resistance and if this response differs in patients with normal glucose tolerance, impaired glucose tolerance and in patients with type 2 diabetes mellitus. To address this question glucose homeostasis will be studied by comparing whole body glucose uptake during a progressively increased oral glucose load with a graded glucose infusion where the blood glucose levels will be kept in the same range as during the oral glucose load in patients with normal glucose tolerance, impaired glucose tolerance and patients with type 2 diabetes mellitus.
Previous studied have shown that different metabolites and bile acids could be involved the regulation of glucose homeostasis. Hence, it is possible that the gut regulates metabolites that could be involved in small intestine-induced insulin resistance described above. The aim of this research is to study metabolomics in plasma collected during the oral glucose tolerance test with increasing load of glucose and the graded glucose infusion where plasma glucose level will be held in the same levels as during the oral glucose tolerance test and study the differences in patients with normal glucose tolerance, impaired glucose tolerance and in patients with type 2 diabetes mellitus.
The expected results in this study will demonstrate that the gut plays an important role in glucose homeostasis and that this system is dysregulated in type 2 diabetes. More importantly, novel factors derived or regulated from the gut that regulate insulin resistance and glucose tolerance will be identified which could be possible targets for future antidiabetic therapies.
Detailed description
The incidence of obesity and obesity-associated metabolic disorders such as insulin resistance and type 2 diabetes is increasing worldwide. To date, bariatric surgery is the only obesity treatment that results in long-term weight reduction. In addition, bariatric surgery has been reported to promote remission of type 2 diabetes and to be a more effective treatment than standard medication for type 2 diabetes. Surprisingly, improvement in glucose homeostasis after some bariatric surgery procedures occurs before weight loss is achieved. The mechanisms behind this improvement are still unclear but a recent study indicates that the bypassing of jejunum could play an important role in glucose homeostasis. Moreover, jejunum-derived proteins present in serum in both human and mice induce insulin resistance in cell cultures of myocytes and in mice. This taken together indicates that the gut may play an important role in glucose homeostasis in type 2 diabetes mellitus.
Metabolomics has recently been regarded to be one of the most suitable technologies for investigating complex diseases such as type 2 diabetes mellitus because it represent a real-time functional portrait of the organisms. Previous studies have shown that different metabolites and bile acids could be involved in the regulation of glucose homeostasis. Hence it is possible that the gut regulates metabolites that could be involved in the impaired glucose tolerance and type 2 diabetes mellitus.
The specific aims of this research project are:
Aim 1: To demonstrate that orally ingested glucose induces insulin resistance and to determine if this regulation of glucose homeostasis differs between subjects with normal glucose tolerance, impaired glucose tolerance and subjects with type 2 diabetes mellitus.
Aim 2: To identify metabolites regulated by the gut that are associated with impaired glucose tolerance and type 2 diabetes mellitus.
To address this aim, differences in glucose kinetics will be studied when glucose is orally administrated (in an oral glucose tolerance test, OGTT) compared to an graded intravenous glucose infusion, were plasma glucose levels are held in the same range as during the OGTT, in subjects with normal glucose tolerance (n = 8), impaired glucose tolerance (n = 8) and type 2 diabetes mellitus (n = 8).
Basal glucose kinetics will first be assessed by double glucose tracer technique. In the basal part of the glucose tolerance tests glucose tracer nr 1 will be infused and then be followed by either a continued infusion and a gradually increasing oral glucose load (25 g, 75 g and 125 g with a 2 h interval during the OGTT) with glucose tracer nr 2 or an graded intravenous glucose tracer infusion where plasma glucose levels are adjusted to those obtained during the OGTTs.
Gas chromatography/mass spectrometry will be used to measure isotopic enrichment of glucose tracers. Insulin, glucagon, total glucagon-like peptide 1 (GLP-1) and C-peptide will be measured by radioimmunoassays repeatedly during the glucose tolerance tests. Glucose kinetics including endogenous glucose production, insulin sensitivity and insulin secretion will be calculated. Differences in glucose kinetics between the oral and intravenous administration of glucose will be calculated and compared in subjects with normal glucose tolerance, impaired glucose tolerance or type 2 diabetes mellitus.
Analysis of metabolomics will be performed in plasma collected during the OGTT and the graded intravenous glucose infusion. Metabolites in plasma samples will be analyzed using two global profiling analytical platforms and a targeted profiling platform. Two-dimensional gas chromatography coupled to time-of-flight mass spectrometry (GCxGC-TOFMS) will be performed to measure small polar metabolites. Molecular lipids will be assessed by a global platform using ultra performance liquid chromatography coupled to quadrupole-TOFMS (UPLC-QTOFMS). A targeted platform based on UPLC coupled to triple-quadrupole MS (UPLC-QqQMS) will be performed to quantify both unconjugated and conjugated forms of bile acids.
Differences in plasma metabolites during OGTT and graded intravenous glucose infusion will be studied to assess information on possible regulation by the gut and the results will be compared in subjects with normal glucose tolerance, impaired glucose tolerance and subjects with type 2 diabetes mellitus.
Significance The expected results in this study will demonstrate that the gut plays an important role in glucose homeostasis and that this system is dysregulated in type 2 diabetes. More importantly, novel factors derived or regulated from the gut that regulate insulin resistance and glucose tolerance will be identified which could be possible targets for future antidiabetic therapies.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients with either normal glucose tolerance, impaired glucose tolerance or with diagnosed type 2 diabetes mellitus will undergo oral glucose tolerance tests with an increasing load of glucose and thereafter isoglycemic intravenous glucose infusion.
| Arm | Type | Receives |
|---|---|---|
| Patients with normal glucose tolerance | Other | Other: Oral glucose tolerance test, Other: Graded intravenous glucose infusionPatients included in this arm will have a plasma glucose below 140 mg/dl after a 2 h oral glucose tolerance test with a glucose load of 75 g. All patients in this arm will undergo oral glucose tolerance test with increasing glucose load and a graded intravenous glucose infusion were plasma glucose levels are held at the same level as during the oral glucose tolerance test. |
| Patients with impaired glucose tolerance | Other | Other: Oral glucose tolerance test, Other: Graded intravenous glucose infusionPatients included in this arm will have a plasma glucose between 140 mg/dl to 199 mg/dl after a 2 h oral glucose tolerance test with a glucose load of 75 g. All patients in this arm will undergo oral glucose tolerance test with increasing glucose load and a graded intravenous glucose infusion were plasma glucose levels are held at the same level as during the oral glucose tolerance test. |
| Patients with type 2 diabetes mellitus | Other | Other: Oral glucose tolerance test, Other: Graded intravenous glucose infusionPatients included in this arm will have a plasma glucose above 200 mg/dl after a 2 h oral glucose tolerance test with a glucose load of 75 g. All patients in this arm will undergo oral glucose tolerance test with increasing glucose load and a graded intravenous glucose infusion were plasma glucose levels are held at the same level as during the oral glucose tolerance test. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 20 and 65
- BMI between 35 and 60 kg/m2
- Ability to understand and comply with the study process.
Key exclusion criteria (12 listed)
- History of type 1 diabetes or secondary diabetes;
- Previous bariatric surgery;
- History of medical problems such as mental impairment;
- Major cardiovascular disease;
- Major gastrointestinal disease;
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 |
|---|---|---|
| Oral glucose tolerance testOral glucose tolerance tests were glucose is administrated orally with an increasing load (25g, 75g, 100 g) | Other | Patients with impaired glucose tolerance, Patients with normal glucose tolerance, Patients with type 2 diabetes mellitus |
| Graded intravenous glucose infusionGraded intravenous glucose infusion where glucose is infused in order to receive an plasma glucose pattern comparable to those received during the oral glucose tolerance tests. | Other | Patients with impaired glucose tolerance, Patients with normal glucose tolerance, Patients with type 2 diabetes mellitus |
Primary outcome
Glucose kinetics
Time frame: 1 year
Whole body glucose uptake will be measured using a double glucose tracer technique during both the oral glucose tolerance test and the graded intravenous glucose infusion.
1 secondary outcome
Metabolomics
Time frame: 1 year
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 26 Jul 2019.
- Derived from this study: PubMed 32385603Mingrone G, Panunzi S, De Gaetano A, Ahlin S, Spuntarelli V, Bondia-Pons I, Barbieri C, Capristo E, Gastaldelli A, Nolan JJ. Insulin sensitivity depends on the route of glucose administration. Diabetologia. 2020 Jul;63(7):1382-1395. doi: 10.1007/s00125-020-05157-w. Epub 2020 May 8.
- 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.
Geltrude Mingrone, MD PhD principal investigator
The Catholic University of the Sacred Heart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral glucose tolerance test and Graded intravenous glucose infusion in people with Type 2 Diabetes Mellitus, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 12 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 26 Jul 2019. 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 Italy. 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?
Glucose kinetics (time frame: 1 year). 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 NCT03223129, which also lists 1 linked publication.
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 26 Jul 2019.