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RecruitingNCT06065930AMIGROSUpdated Oct 4, 2023

Adaptive Mechanisms In GRown up ObeSity Study (AMIGROS)

An observational study in Obesity and Type 2 Diabetes, sponsored by Vastra Gotaland Region. Recruiting at 1 site in Sweden. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-04.

Sponsored by Vastra Gotaland Region · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 5 months later.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
45
Ages
40 Years to 70 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Obesity
  • Type 2 Diabetes

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Keywords

  • Adipose cells
  • Fatty acids
  • Microdialysis
  • Stromal vascular fraction
  • Ectopic lipid accumulation
  • Fasting hyperinsulinemia
  • Insulin resistance
  • Amino acids
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 45 is below the median of 135 across 1,283 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Vastra Gotaland Region is the lead sponsor of 267 studies on the registry; 107 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Inclusion criteria

  1. Men and women of age: 40.0 - 70.0 years
  2. BMI: 18.0 - 25.0 kg/m2 (lean subjects) and BMI 30.0 - 38.0 kg/m2 (Ob-IS and Ob-IR)
  3. Fasting insulin \< 9.0 mU/l (lean and Ob-IS subjects) and fasting insulin > 9.0 mU/l (Ob-IR)
  4. Fasting glucose \< 6.1 mmol/l
  5. Body temperature \< 37.5°C
  6. First-degree relative with known T2D in Ob-IR
  7. Weight stable ± 5 kg \< 3 months before screening
  8. Fluent in Swedish and can follow given instructions
  9. Consent given to participate

Exclusion criteria

Exclusion Criteria:

  1. First-degree relative with known T2D in lean or Ob-IS subjects
  2. Alcohol intake > 10 units/week or known high alcohol intake \< 10 years back in time
  3. 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
  4. Regular physical activity corresponding to Saltin-Gimby level 4
  5. Special diet eg Atkins or 5:2 for weight reduction. Vegetarian food accepted if duration > 1 year
  6. Impaired fasting glucose (IFG) (venous fasting plasma glucose 6.1-6.9 mmol/l)
  7. Type 2 diabetes according to ADA criteria
  8. 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
  9. Heart failure (NYHA II-IV) or cardiac arrhytmia that needs medical treatment
  10. Previous cerebral infarction or transitory ischemic episodes (TIA) treated with platelet inhibitors or other anticoagulants
  11. Peripheral arterial insufficiency eg claudication
  12. Hypertension >170/105 mmHg at screening or more than one class of drugs for treatment of known hypertension
  13. Lipid disorder defined as fasting serum triglycerides > 5.0 mmol/l or serum cholesterol > 7.5 mmol/l
  14. 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
  15. Renal failure defined as absolute estimated glomerular filtration rate (eGFRcreatinine) \< 60 ml/min/1.73 m2
  16. Hypothyroidism defined as TSH > 4.0 mIE/l and symptoms
  17. Liver disease e.g. hepatitis B, cirrhosis or conditions where AST or ALT are > 2 times UNL
  18. Systemic inflammatory disease e.g. rheumatoid arthritis, ulcerative cholitis or Chrons disease. Celiac disease, dyspepsia or IBS are excepted
  19. Chronic bronchitis or chronic obstructive pulmonary with disease symptoms
  20. Previous pancreatitis or other disease in pancreas that needs treatment
  21. Migraine elicited by stress
  22. Spinal insufficiency causing inconvenience lying in supine position during the study day
  23. Drug addiction interfering with the study procedures
  24. Psychiatric insufficiency interfering with the study procedures
  25. Medication with potential to affect adipose tissue metabolism that can not be stopped 10 days before the study days
  26. Treatment with beta-blockers
  27. Less than three months from previous use of antibiotics
  28. Cancer disease \< 5 years since diagnosis
  29. Physical examination or laboratory results indicating that participation in the study is inappropriate
  30. Pregnancy or intention to be pregnant during the study
  31. Shift work > 1 time per week that might interfere with the circadian rhytm
  32. Other reasons that causes the PI to believe that participation is inappropriate
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
45 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

    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.

    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.

    Device: Subcutaneous microdialysis

Interventions

  • DeviceSubcutaneous microdialysis

    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.

06

What researchers measure

Primary outcomes

  1. Fasting galectin-1 concentration in subcutaneous interstitial fluid

    Comparison between eligible Ob-IS and Ob-IR subjects \< 3 weeks after enrolment

    Time frame: Three weeks

  2. Fasting Neuropilin-1 concentration in subcutaneous interstitial fluid

    Comparison between eligible Ob-IS and Ob-IR subjects \< 3 weeks after enrolment

    Time frame: Three weeks

Secondary outcomes

  1. Fasting serum galectin-1 concentrations

    Comparison between eligible Ob-IS and Ob-IR subjects \< 3 weeks after enrolment

    Time frame: Three weeks

  2. Fasting serum neuropilin-1 concentrations

    Comparison between eligible Ob-IS and Ob-IR subjects \< 3 weeks after enrolment

    Time frame: Three weeks

  3. Fasting fatty acid levels in subcutaneous dialysates

    Comparison between eligible Ob-IS and Ob-IR subjects \< 3 weeks after enrolment

    Time frame: Three weeks

  4. Fasting plasma fatty acid concentrations

    Comparison between eligible Ob-IS and Ob-IR subjects \< 3 weeks after enrolment

    Time frame: Three weeks

  5. Fasting amino acid profile in subcutaneous dialysates

    Comparison between eligible Ob-IS and Ob-IR subjects \< 3 weeks after enrolment

    Time frame: Three weeks

  6. Fasting serum amino acid concentrations

    Comparison between eligible Ob-IS and Ob-IR subjects \< 3 weeks after enrolment

    Time frame: Three weeks

  7. Circulating metabolome including lipoprotein-related parameters measured by Mass Spectrometry

    Comparison between eligible Ob-IS and Ob-IR subjects \< 3 weeks after enrolment

    Time frame: Three weeks

  8. Circulating lipidome including lipid derivatives measured by Mass Spectrometry

    Comparison between eligible Ob-IS and Ob-IR subjects \< 3 weeks after enrolment

    Time frame: Three weeks

  9. Peptides identified by Mass Spectrometry in subcutaneous dialysates

    Comparison between eligible Ob-IS and Ob-IR subjects \< 3 weeks after enrolment

    Time frame: Three weeks

  10. Ectopic lipid accumulation assessed by magnetic resonance imaging in relative measures

    Comparison between eligible Ob-IS and Ob-IR subjects \< 9 weeks after enrolment

    Time frame: Nine weeks

  11. RNA sequencing results of subcutaneous adipose cells

    Comparison between eligible Ob-IS and Ob-IR subjects \< 6 weeks after enrolment

    Time frame: Six weeks

  12. 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

    Time frame: Six weeks

  13. 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

    Time frame: Six weeks

  14. Function of microvascular endothelial cells in subcutaneous stromal vascular fraction

    Comparison between eligible Ob-IS and Ob-IR subjects \< 6 weeks after enrolment

    Time frame: Six weeks

  15. Messenger RNA expression in whole adipose tissue

    Comparison between eligible Ob-IS and Ob-IR subjects \< 6 weeks after enrolment

    Time frame: Six weeks

  16. Dysbiosis in faeces assessed by 16S rRNA gene sequencing

    Comparison between eligible Ob-IS and Ob-IR subjects \< 6 weeks after enrolment

    Time frame: Six weeks

  17. Metabolites in urine including acylcarnitines measured by Mass Spectrometry

    Comparison between eligible Ob-IS and Ob-IR subjects \< 3 weeks after enrolment

    Time frame: Three weeks

07

Study locations

1 of 1 sites recruiting
  • Gothia Forum CTC
    Gothenburg, Region Vastra Gotaland SE-413 46, Sweden
    • Anna-Carin Varvne, Manager · Contact · anna-carin.varvne@vgregion.se · 46 70 082 50 91
    • Sari Huusko, Team leader · Contact · saari.huusko@vgregion.se · 46 70 082 34 22
    • Emanuel Fryk, MD, PhD · Sub investigator
    • Vagner Silva, PhD · Sub investigator
    • Jakob Bellman, MD · Sub investigator
    • Ingrid Wernstedt Asterholm, Prof · Sub investigator
    • Milica Vujicic, PhD · Sub investigator
    • Marco Bauza Thorbrügge, PhD · Sub investigator
    Recruiting
08

References and documents

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 27282870 ↗
  • Drake 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 34743218 ↗
  • Fryk 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 33712379 ↗
  • Fryk 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 ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06065930
Lead sponsor
Vastra Gotaland Region
Collaborators
Göteborg University
Responsible party
Sponsor
First posted
Oct 4, 2023
Start date
May 5, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Oct 4, 2023

Study contacts

Per-Anders E Jansson, Prof
Contact
per-anders.jansson@wlab.gu.se
46 70 203 30 10
Vagner R Silva, PhD
Contact
vagner.silva@wlab.gu.se
46 76 849 77 03
Per-Anders Jansson, Prof
principal investigator · Region Vastra Gotaland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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