Adaptive Mechanisms In GRown up ObeSity Study (AMIGROS)

Launched by VASTRA GOTALAND REGION · Sep 26, 2023

Keywords

ClinConnect Summary

The AMIGROS study is looking into how a specific protein called galectin-1 might help our bodies adapt to obesity and type 2 diabetes. Researchers want to understand if galectin-1 plays a role in how fat tissue behaves in people who are overweight or have type 2 diabetes. They believe this protein may be key to finding new ways to manage these conditions, especially since it seems to change during overfeeding and could predict the risk of developing diabetes.

If you’re between 40 and 70 years old, have a body mass index (BMI) between 18 and 25 (considered lean) or 30 and 38 (considered overweight), and meet certain health criteria, you might be eligible to participate. Participants will need to be stable in their weight, fluent in Swedish, and willing to follow study instructions. During the study, you can expect to undergo various assessments to help researchers learn more about how galectin-1 functions in the body. It's important to note that individuals with certain health issues, like heart disease or diabetes, may not qualify for this trial. This study hopes to provide valuable insights that could improve treatment options for obesity and diabetes in the future.

Gender

ALL

Eligibility 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