Understanding how galectin-1 affects obesity and diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the role of galectin-1 in adaptive mechanisms within adipose tissue among obese insulin-sensitive and insulin-resistant individuals compared to lean healthy controls. The research will involve subcutaneous microdialysis to analyze the secretion of molecules from adipose tissue that may influence insulin secretion when blood glucose levels are normal. By examining these mechanisms, the study seeks to uncover how certain individuals maintain normal fatty acid levels despite obesity, potentially leading to new insights into diabetes management.

Why it matters

Who can join: the full rules

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

Where it's running

• Gothia Forum CTC
  Gothenburg, Region Vastra Gotaland, Sweden Recruiting

Study contacts

• Principal investigator: Per-Anders Jansson, Prof — Region Vastra Gotaland
• Study coordinator: Per-Anders E Jansson, Prof
• Email: per-anders.jansson@wlab.gu.se
• Phone: 46 70 203 30 10

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.