ObesityAMIGROSNCT06065930
Adaptive Mechanisms In GRown up ObeSity Study (AMIGROS)
An observational study of Obesity and Type 2 Diabetes, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
The investigator recently showed that the glycan-binding adipokine galectin-1 increased during overfeeding and that galectin-1 independently could predict type 2 diabetes. Further, the molecules that induce insulin release in the fasting state when blood glucose is normal remain elusive. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes
- What is being tested?
- Subcutaneous microdialysis
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 45 participants
- Where
- 1 siteSweden
- Study dates
- 5 May 2023to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Obese subjects and healthy lean controls will be recruited by advertisements in local newspapers and social media. Catchment area is western Sweden having about 1.5 million inhabitants.
Who may be able to join
- Men and women of age: 40.0 - 70.0 years
- BMI: 18.0 - 25.0 kg/m2 (lean subjects) and BMI 30.0 - 38.0 kg/m2 (Ob-IS and Ob-IR)
- Fasting insulin < 9.0 mU/l (lean and Ob-IS subjects) and fasting insulin > 9.0 mU/l (Ob-IR)
- Fasting glucose < 6.1 mmol/l
- Body temperature < 37.5°C
- First-degree relative with known T2D in Ob-IR
Show all 9Show fewer
- Weight stable ± 5 kg < 3 months before screening
- Fluent in Swedish and can follow given instructions
- Consent given to participate
Who cannot join
- First-degree relative with known T2D in lean or Ob-IS subjects
- Alcohol intake > 10 units/week or known high alcohol intake < 10 years back in time
- Daily use of cigarettes or daily frequent use of smokeless tobacco not enabling the participant to suspend nicotine during a visit at the research center without getting abstinent
- Regular physical activity corresponding to Saltin-Gimby level 4
- Special diet eg Atkins or 5:2 for weight reduction. Vegetarian food accepted if duration > 1 year
- Impaired fasting glucose (IFG) (venous fasting plasma glucose 6.1-6.9 mmol/l)
Show all 32Show fewer
- Type 2 diabetes according to ADA criteria
- Ongoing or previous ischemic heart disease, eg angina pectoris, unstable angina or previous myocardial infarction treated with platelet inhibitors or non vitamin-K oral anticoagulants
- Heart failure (NYHA II-IV) or cardiac arrhytmia that needs medical treatment
- Previous cerebral infarction or transitory ischemic episodes (TIA) treated with platelet inhibitors or other anticoagulants
- Peripheral arterial insufficiency eg claudication
- Hypertension >170/105 mmHg at screening or more than one class of drugs for treatment of known hypertension
- Lipid disorder defined as fasting serum triglycerides > 5.0 mmol/l or serum cholesterol > 7.5 mmol/l
- Hematologic diseases such as anemia not being substituted (Hb < 130 g/l in males and Hv < 120 g/l in females) or disease causing bleeding disorder
- Renal failure defined as absolute estimated glomerular filtration rate (eGFRcreatinine) < 60 ml/min/1.73 m2
- Hypothyroidism defined as TSH > 4.0 mIE/l and symptoms
- Liver disease e.g. hepatitis B, cirrhosis or conditions where AST or ALT are > 2 times UNL
- Systemic inflammatory disease e.g. rheumatoid arthritis, ulcerative cholitis or Chrons disease. Celiac disease, dyspepsia or IBS are excepted
- Chronic bronchitis or chronic obstructive pulmonary with disease symptoms
- Previous pancreatitis or other disease in pancreas that needs treatment
- Migraine elicited by stress
- Spinal insufficiency causing inconvenience lying in supine position during the study day
- Drug addiction interfering with the study procedures
- Psychiatric insufficiency interfering with the study procedures
- Medication with potential to affect adipose tissue metabolism that can not be stopped 10 days before the study days
- Treatment with beta-blockers
- Less than three months from previous use of antibiotics
- Cancer disease < 5 years since diagnosis
- Physical examination or laboratory results indicating that participation in the study is inappropriate
- Pregnancy or intention to be pregnant during the study
- Shift work > 1 time per week that might interfere with the circadian rhytm
- Other reasons that causes the PI to believe that participation is inappropriate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Gothia Forum CTC
Gothenburg, Region Vastra Gotaland, SE-413 46
Anna-Carin Varvne, Manager, 46 70 082 50 91, anna-carin.varvne@vgregion.se
Sari Huusko, Team leader, 46 70 082 34 22, saari.huusko@vgregion.se
About this study
Official title: Mechanistic Studies in Human Subcutaneous Adipose Tissue
The investigator recently showed that the glycan-binding adipokine galectin-1 increased during overfeeding and that galectin-1 independently could predict type 2 diabetes. Further, the molecules that induce insulin release in the fasting state when blood glucose is normal remain elusive. It is possible that galectin-1 is involved in adaptive mechanisms in adipose tissue in obese subjects.
Read the detailed description
The investigator will define adaptive mechanisms in adipose tissue associated with galectin-1 in obese insulin-sensitive (Ob-IS) subjects compared with obese insulin-resistant (Ob-IR) subjects and lean healthy controls. Further, the investigator will study molecules secreted from adipose tissue that might trigger insulin secretion when blood glucose is normal.
The investigator hypothesizes that Ob-IS subjects keep fatty acid levels normal through an adaptive response in adipose tissue that involves up-regulation of galectin-1 for dampening of immune cell activity and stimulation of lipolysis.
- Conditions
- Obesity, Type 2 Diabetes
- Being tested
- Subcutaneous microdialysis
- Keywords
- Adipose cells, Fatty acids, Microdialysis, Stromal vascular fraction, Ectopic lipid accumulation, Fasting hyperinsulinemia, Insulin resistance, Amino acids
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous microdialysisDevice
Group with Ob-IS participants, collection of abdominal subcutaneous interstitial dialysates after an overnight´s fast for later measurements of metabolites and peptides eg galectin-1.
Group with Ob-IR participants, collection of abdominal subcutaneous interstitial dialysates after an overnight´s fast for later measurements of metabolites and peptides eg galectin-1.
Group with Leans, collection of abdominal subcutaneous interstitial dialysates after an overnight´s fast for later measurements of metabolites and peptides eg galectin-1.
| Study group | Role | What they receive |
|---|---|---|
| Obese insulin-sensitive subjects (Ob-IS) | Obese Insulin Sensitive subjects (BMI > 30 kg/m2, fasting insulin < 9.0 mU/l and fasting plasma glucose < 6.1 mmol/l) undergoing subcutaneous microdialysis, needle biopsy, glucose clamp and MRI. Receives: Device: Subcutaneous microdialysis | |
| Obese insulin-resistant subjects (Ob-IR) | Obese Insulin Resistant subjects (BMI > 30 kg/m2, fasting insulin > 9.0 mU/l and fasting plasma glucose < 6.1 mmol/l) undergoing subcutaneous microdialysis, needle biopsy, glucose clamp and MRI. Receives: Device: Subcutaneous microdialysis | |
| Lean healthy controls (Lean) | Lean healthy controls (BMI < 25 kg/m2, fasting insulin < 9.0 mU/l and fasting plasma glucose < 6.1 mmol/l) undergoing subcutaneous microdialysis, needle biopsy, glucose clamp and MRI. Receives: Device: Subcutaneous microdialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting galectin-1 concentration in subcutaneous interstitial fluid
Comparison between eligible Ob-IS and Ob-IR subjects < 3 weeks after enrolment
Measured: Three weeks
Fasting Neuropilin-1 concentration in subcutaneous interstitial fluid
Comparison between eligible Ob-IS and Ob-IR subjects < 3 weeks after enrolment
Measured: Three weeks
Secondary outcomes (17)
Fasting serum galectin-1 concentrations
Comparison between eligible Ob-IS and Ob-IR subjects < 3 weeks after enrolment
Measured: Three weeks
Fasting serum neuropilin-1 concentrations
Comparison between eligible Ob-IS and Ob-IR subjects < 3 weeks after enrolment
Measured: Three weeks
Fasting fatty acid levels in subcutaneous dialysates
Comparison between eligible Ob-IS and Ob-IR subjects < 3 weeks after enrolment
Measured: Three weeks
Fasting plasma fatty acid concentrations
Comparison between eligible Ob-IS and Ob-IR subjects < 3 weeks after enrolment
Measured: Three weeks
Fasting amino acid profile in subcutaneous dialysates
Comparison between eligible Ob-IS and Ob-IR subjects < 3 weeks after enrolment
Measured: Three weeks
Fasting serum amino acid concentrations
Comparison between eligible Ob-IS and Ob-IR subjects < 3 weeks after enrolment
Measured: Three weeks
Circulating metabolome including lipoprotein-related parameters measured by Mass Spectrometry
Comparison between eligible Ob-IS and Ob-IR subjects < 3 weeks after enrolment
Measured: Three weeks
Circulating lipidome including lipid derivatives measured by Mass Spectrometry
Comparison between eligible Ob-IS and Ob-IR subjects < 3 weeks after enrolment
Measured: Three weeks
Peptides identified by Mass Spectrometry in subcutaneous dialysates
Comparison between eligible Ob-IS and Ob-IR subjects < 3 weeks after enrolment
Measured: Three weeks
Ectopic lipid accumulation assessed by magnetic resonance imaging in relative measures
Comparison between eligible Ob-IS and Ob-IR subjects < 9 weeks after enrolment
Measured: Nine weeks
RNA sequencing results of subcutaneous adipose cells
Comparison between eligible Ob-IS and Ob-IR subjects < 6 weeks after enrolment
Measured: Six weeks
Function of immune cells in subcutaneous stromal vascular fraction characterized by Fluorescence Activated Cell Sorting (FACS)
Comparison between eligible Ob-IS and Ob-IR subjects < 6 weeks after enrolment
Measured: Six weeks
Activation of insulin signaling proteins in adipose cells assessed by Western blot
Comparison between eligible Ob-IS and Ob-IR subjects < 6 weeks after enrolment
Measured: Six weeks
Function of microvascular endothelial cells in subcutaneous stromal vascular fraction
Comparison between eligible Ob-IS and Ob-IR subjects < 6 weeks after enrolment
Measured: Six weeks
Messenger RNA expression in whole adipose tissue
Comparison between eligible Ob-IS and Ob-IR subjects < 6 weeks after enrolment
Measured: Six weeks
Dysbiosis in faeces assessed by 16S rRNA gene sequencing
Comparison between eligible Ob-IS and Ob-IR subjects < 6 weeks after enrolment
Measured: Six weeks
Metabolites in urine including acylcarnitines measured by Mass Spectrometry
Comparison between eligible Ob-IS and Ob-IR subjects < 3 weeks after enrolment
Measured: Three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start5 May 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Göteborg University
- Responsible party
- Sponsor
- Investigators
- Per-Anders Jansson, Prof, Principal investigator, Region Vastra Gotaland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065930
- Sponsor's protocol ID
- 2023-02051-02
- Other IDs
- 2023
- Acronym
- AMIGROS
- Status last verified
- May 2023
- First submitted
- 11 Jul 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sensitive personal data will be collected. Results will be shared if possible in the light of GDPR and other regulations, on an individual basis, after contact with the PI.
Publications
Fryk E, Sundelin JP, Strindberg L, Pereira MJ, Federici M, Marx N, Nystrom FH, Schmelz M, Svensson PA, Eriksson JW, Boren J, Jansson PA. Microdialysis and proteomics of subcutaneous interstitial fluid reveals increased galectin-1 in type 2 diabetes patients. Metabolism. 2016 Jul;65(7):998-1006. doi: 10.1016/j.metabol.2016.04.003. Epub 2016 Apr 13.
PubMed 27282870Drake I, Fryk E, Strindberg L, Lundqvist A, Rosengren AH, Groop L, Ahlqvist E, Boren J, Orho-Melander M, Jansson PA. The role of circulating galectin-1 in type 2 diabetes and chronic kidney disease: evidence from cross-sectional, longitudinal and Mendelian randomisation analyses. Diabetologia. 2022 Jan;65(1):128-139. doi: 10.1007/s00125-021-05594-1. Epub 2021 Nov 7.
PubMed 34743218Fryk E, Olausson J, Mossberg K, Strindberg L, Schmelz M, Brogren H, Gan LM, Piazza S, Provenzani A, Becattini B, Lind L, Solinas G, Jansson PA. Hyperinsulinemia and insulin resistance in the obese may develop as part of a homeostatic response to elevated free fatty acids: A mechanistic case-control and a population-based cohort study. EBioMedicine. 2021 Mar;65:103264. doi: 10.1016/j.ebiom.2021.103264. Epub 2021 Mar 9.
PubMed 33712379Fryk E, Silva VRR, Jansson PA. Galectin-1 in Obesity and Type 2 Diabetes. Metabolites. 2022 Sep 30;12(10):930. doi: 10.3390/metabo12100930.
PubMed 36295832
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Studies in Human Subcutaneous Adipose Tissue
- ClinicalTrials.gov ID
- NCT06065930
- Acronym / sponsor ID
- AMIGROS / 2023-02051-02
- Conditions
- Obesity, Type 2 Diabetes
- Keywords
- Adipose cells, Fatty acids, Microdialysis, Stromal vascular fraction, Ectopic lipid accumulation, Fasting hyperinsulinemia, Insulin resistance, Amino acids
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Göteborg University
- Study start
- 5 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Oct 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 investigator recently showed that the glycan-binding adipokine galectin-1 increased during overfeeding and that galectin-1 independently could predict type 2 diabetes. Further, the molecules that induce insulin release in the fasting state when blood glucose is normal remain elusive. It is possible that galectin-1 is involved in adaptive mechanisms in adipose tissue in obese subjects.
Detailed description
The investigator will define adaptive mechanisms in adipose tissue associated with galectin-1 in obese insulin-sensitive (Ob-IS) subjects compared with obese insulin-resistant (Ob-IR) subjects and lean healthy controls. Further, the investigator will study molecules secreted from adipose tissue that might trigger insulin secretion when blood glucose is normal.
The investigator hypothesizes that Ob-IS subjects keep fatty acid levels normal through an adaptive response in adipose tissue that involves up-regulation of galectin-1 for dampening of immune cell activity and stimulation of lipolysis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese insulin-sensitive subjects (Ob-IS) | – | Device: Subcutaneous microdialysisObese Insulin Sensitive subjects (BMI > 30 kg/m2, fasting insulin < 9.0 mU/l and fasting plasma glucose < 6.1 mmol/l) undergoing subcutaneous microdialysis, needle biopsy, glucose clamp and MRI. |
| Obese insulin-resistant subjects (Ob-IR) | – | Device: Subcutaneous microdialysisObese Insulin Resistant subjects (BMI > 30 kg/m2, fasting insulin > 9.0 mU/l and fasting plasma glucose < 6.1 mmol/l) undergoing subcutaneous microdialysis, needle biopsy, glucose clamp and MRI. |
| Lean healthy controls (Lean) | – | Device: Subcutaneous microdialysisLean healthy controls (BMI < 25 kg/m2, fasting insulin < 9.0 mU/l and fasting plasma glucose < 6.1 mmol/l) undergoing subcutaneous microdialysis, needle biopsy, glucose clamp and MRI. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Obese subjects and healthy lean controls will be recruited by advertisements in local newspapers and social media. Catchment area is western Sweden having about 1.5 million inhabitants.
Key inclusion criteria (9 listed)
- Men and women of age: 40.0 - 70.0 years
- BMI: 18.0 - 25.0 kg/m2 (lean subjects) and BMI 30.0 - 38.0 kg/m2 (Ob-IS and Ob-IR)
- Fasting insulin < 9.0 mU/l (lean and Ob-IS subjects) and fasting insulin > 9.0 mU/l (Ob-IR)
- Fasting glucose < 6.1 mmol/l
- Body temperature < 37.5°C
Key exclusion criteria (32 listed)
- First-degree relative with known T2D in lean or Ob-IS subjects
- Alcohol intake > 10 units/week or known high alcohol intake < 10 years back in time
- Daily use of cigarettes or daily frequent use of smokeless tobacco not enabling the participant to suspend nicotine during a visit at the research center without getting abstinent
- Regular physical activity corresponding to Saltin-Gimby level 4
- Special diet eg Atkins or 5:2 for weight reduction. Vegetarian food accepted if duration > 1 year
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 |
|---|---|---|
| Subcutaneous microdialysisGroup with Ob-IS participants, collection of abdominal subcutaneous interstitial dialysates after an overnight´s fast for later measurements of metabolites and peptides eg galectin-1. Group with Ob-IR participants, collection of abdominal subcutaneous interstitial dialysates after an overnight´s fast for later measurements of metabolites and peptides eg galectin-1. Group with Leans, collection of abdominal subcutaneous interstitial dialysates after an overnight´s fast for later measurements of metabolites and peptides eg galectin-1. | Device | Lean healthy controls (Lean), Obese insulin-resistant subjects (Ob-IR), Obese insulin-sensitive subjects (Ob-IS) |
Primary outcome
Fasting galectin-1 concentration in subcutaneous interstitial fluid
Time frame: Three weeks
Comparison between eligible Ob-IS and Ob-IR subjects < 3 weeks after enrolment
Fasting Neuropilin-1 concentration in subcutaneous interstitial fluid
Time frame: Three weeks
Comparison between eligible Ob-IS and Ob-IR subjects < 3 weeks after enrolment
17 secondary outcomes
Fasting serum galectin-1 concentrations
Time frame: Three weeks
Fasting serum neuropilin-1 concentrations
Time frame: Three weeks
Fasting fatty acid levels in subcutaneous dialysates
Time frame: Three weeks
Fasting plasma fatty acid concentrations
Time frame: Three weeks
Fasting amino acid profile in subcutaneous dialysates
Time frame: Three weeks
Fasting serum amino acid concentrations
Time frame: Three weeks
Circulating metabolome including lipoprotein-related parameters measured by Mass Spectrometry
Time frame: Three weeks
Circulating lipidome including lipid derivatives measured by Mass Spectrometry
Time frame: Three weeks
Peptides identified by Mass Spectrometry in subcutaneous dialysates
Time frame: Three weeks
Ectopic lipid accumulation assessed by magnetic resonance imaging in relative measures
Time frame: Nine weeks
RNA sequencing results of subcutaneous adipose cells
Time frame: Six weeks
Function of immune cells in subcutaneous stromal vascular fraction characterized by Fluorescence Activated Cell Sorting (FACS)
Time frame: Six weeks
Activation of insulin signaling proteins in adipose cells assessed by Western blot
Time frame: Six weeks
Function of microvascular endothelial cells in subcutaneous stromal vascular fraction
Time frame: Six weeks
Messenger RNA expression in whole adipose tissue
Time frame: Six weeks
Dysbiosis in faeces assessed by 16S rRNA gene sequencing
Time frame: Six weeks
Metabolites in urine including acylcarnitines measured by Mass Spectrometry
Time frame: Three weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Results publication: PubMed 27282870Fryk E, Sundelin JP, Strindberg L, Pereira MJ, Federici M, Marx N, Nystrom FH, Schmelz M, Svensson PA, Eriksson JW, Boren J, Jansson PA. Microdialysis and proteomics of subcutaneous interstitial fluid reveals increased galectin-1 in type 2 diabetes patients. Metabolism. 2016 Jul;65(7):998-1006. doi: 10.1016/j.metabol.2016.04.003. Epub 2016 Apr 13.
- Results publication: PubMed 34743218Drake I, Fryk E, Strindberg L, Lundqvist A, Rosengren AH, Groop L, Ahlqvist E, Boren J, Orho-Melander M, Jansson PA. The role of circulating galectin-1 in type 2 diabetes and chronic kidney disease: evidence from cross-sectional, longitudinal and Mendelian randomisation analyses. Diabetologia. 2022 Jan;65(1):128-139. doi: 10.1007/s00125-021-05594-1. Epub 2021 Nov 7.
- Results publication: PubMed 33712379Fryk E, Olausson J, Mossberg K, Strindberg L, Schmelz M, Brogren H, Gan LM, Piazza S, Provenzani A, Becattini B, Lind L, Solinas G, Jansson PA. Hyperinsulinemia and insulin resistance in the obese may develop as part of a homeostatic response to elevated free fatty acids: A mechanistic case-control and a population-based cohort study. EBioMedicine. 2021 Mar;65:103264. doi: 10.1016/j.ebiom.2021.103264. Epub 2021 Mar 9.
- Results publication: PubMed 36295832Fryk E, Silva VRR, Jansson PA. Galectin-1 in Obesity and Type 2 Diabetes. Metabolites. 2022 Sep 30;12(10):930. doi: 10.3390/metabo12100930.
- Individual participant dataSharing planned: Yes. Sensitive personal data will be collected. Results will be shared if possible in the light of GDPR and other regulations, on an individual basis, after contact with the PI.
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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.
Per-Anders Jansson, Prof principal investigator
Region Vastra Gotaland
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 Obesity and Type 2 Diabetes, run by Vastra Gotaland Region at 1 site in Sweden.
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 9 inclusion and 32 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: looking for participants now, as of the sponsor's last update on 4 Oct 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Per-Anders E Jansson, Prof (46 70 203 30 10, per-anders.jansson@wlab.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting galectin-1 concentration in subcutaneous interstitial fluid (time frame: Three weeks). 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 NCT06065930, which also lists 4 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 Oct 2023.