Understanding how galectin-1 affects obesity and diabetes
Mechanistic Studies in Human Subcutaneous Adipose Tissue
This study looks at how a protein called galectin-1 affects fat tissue in people with obesity and diabetes to see if it helps explain why some people can keep their blood sugar levels normal despite being overweight.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Gothenburg, Region Vastra Gotaland) |
| Trial ID | NCT06065930 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are men and women aged 40 to 70 with specific BMI ranges and insulin levels, including both obese insulin-sensitive and insulin-resistant individuals.
Not a fit: Patients who are lean with a first-degree relative having type 2 diabetes or those with a history of high alcohol intake may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new strategies for managing obesity and type 2 diabetes by targeting galectin-1 and its effects on insulin sensitivity.
How similar studies have performed: While the specific approach of studying galectin-1 in this context may be novel, similar studies have shown promise in understanding the mechanisms of obesity and diabetes.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Gothenburg, Region Vastra Gotaland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.