Actively Recruiting

Age: 40Years - 70Years
All Genders
Healthy Volunteers
NCT06065930

Adaptive Mechanisms In GRown up ObeSity Study (AMIGROS)

Led by Vastra Gotaland Region · Updated on 2023-10-04

45

Participants Needed

1

Research Sites

295 weeks

Total Duration

On this page

Sponsors

V

Vastra Gotaland Region

Lead Sponsor

G

Göteborg University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Adaptive Mechanisms In GRown up ObeSity Study (AMIGROS)

Who Can Participate

Age: 40Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women aged 40 to 70 years
  • BMI 18.0 to 25.0 kg/m2 for lean subjects and BMI 30.0 to 38.0 kg/m2 for obese insulin-sensitive and insulin-resistant subjects
  • Fasting insulin less than 9.0 mU/l for lean and obese insulin-sensitive subjects, and fasting insulin greater than 9.0 mU/l for obese insulin-resistant subjects
  • Fasting glucose less than 6.1 mmol/l
  • Body temperature below 37.5 0C
  • First-degree relative with known type 2 diabetes for obese insulin-resistant subjects
  • Weight stable within �b15 kg for less than 3 months before screening
  • Fluent in Swedish and able to follow instructions
  • Provided consent to participate
Not Eligible

You will not qualify if you...

  • First-degree relative with known type 2 diabetes for lean or obese insulin-sensitive subjects
  • Alcohol intake above 10 units per week or known high alcohol intake less than 10 years prior
  • Daily use of cigarettes or frequent daily use of smokeless tobacco that cannot be suspended during study visits
  • Regular physical activity at Saltin-Gimby level 4
  • Special diets such as Atkins or 5:2 for weight reduction; vegetarian diet accepted if longer than 1 year
  • Impaired fasting glucose (venous fasting plasma glucose 6.1-6.9 mmol/l)
  • Diagnosis of type 2 diabetes according to ADA criteria
  • Ongoing or previous ischemic heart disease treated with platelet inhibitors or non-vitamin-K oral anticoagulants
  • Heart failure (NYHA II-IV) or cardiac arrhythmia needing treatment
  • Previous cerebral infarction or transient ischemic attack treated with platelet inhibitors or anticoagulants
  • Peripheral arterial insufficiency such as claudication
  • Hypertension above 170/105 mmHg at screening or requiring more than one class of antihypertensive drugs
  • Lipid disorders with fasting serum triglycerides over 5.0 mmol/l or serum cholesterol over 7.5 mmol/l
  • Hematologic diseases such as untreated anemia or bleeding disorders
  • Renal failure with estimated glomerular filtration rate below 60 ml/min/1.73 m2
  • Hypothyroidism with TSH over 4.0 mIE/l and symptoms
  • Liver diseases such as hepatitis B, cirrhosis, or elevated AST/ALT over 2 times normal
  • Systemic inflammatory diseases except celiac disease, dyspepsia, or IBS
  • Chronic bronchitis or COPD with symptoms
  • Previous pancreatitis or pancreatic diseases needing treatment
  • Stress-induced migraine
  • Spinal problems preventing lying down during study
  • Drug addiction or psychiatric issues interfering with study
  • Medications affecting adipose metabolism not stopped 10 days before study
  • Use of beta-blockers
  • Antibiotic use within 3 months
  • Cancer diagnosed less than 5 years ago
  • Physical or lab findings making participation inappropriate
  • Pregnancy or intention to become pregnant during study
  • Shift work more than once per week affecting circadian rhythm
  • Other reasons judged by investigator to make participation inappropriate

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Gothia Forum CTC

Gothenburg, Region Vastra Gotaland, Sweden, SE-413 46

Actively Recruiting

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Research Team

P

Per-Anders E Jansson, Prof

CONTACT

V

Vagner R Silva, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Adaptive Mechanisms In GRown up ObeSity Study (AMIGROS) | DecenTrialz