Status:
RECRUITING
Adaptive Mechanisms In GRown up ObeSity Study (AMIGROS)
Lead Sponsor:
Vastra Gotaland Region
Collaborating Sponsors:
Göteborg University
Conditions:
Obesity
Type 2 Diabetes
Eligibility:
All Genders
40-70 years
Brief 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 ...
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 lea...
Eligibility Criteria
Inclusion
- 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
- Weight stable ± 5 kg \< 3 months before screening
- Fluent in Swedish and can follow given instructions
- Consent given to participate
Exclusion
- 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)
- 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
Key Trial Info
Start Date :
May 5 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06065930
Start Date
May 5 2023
End Date
December 31 2028
Last Update
October 4 2023
Active Locations (1)
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1
Gothia Forum CTC
Gothenburg, Region Vastra Gotaland, Sweden, SE-413 46