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Completed

NCT Number: NCT02598544

Endocrine Regulation of Lipolysis in Obesity and Diabetes

Adipose tissue (AT) dysfunction is a commonly observed feature of metabolic dysfunction in obesity and diabetes. An important characteristic when examining AT function is the capacity to break down stored lipids (i.e. lipolysis) and its regulation. In the present study, the aim was to investigate whether atrial natriuretic peptide-mediated lipolysis is altered in different adipose tissue depots (subcutaneous and visceral adipose tissue) of obese subjects with or without type 2 diabetes, compared to age-matched lean men. Eventually, the knowledge gained from this research will contribute to a better understanding of the present adipose tissue dysfunction and to the optimization of exercise programs for people with obesity and diabetes.

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Key information

Conditions

Obesity Body Weight Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hasselt University, Diepenbeek, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Lean group: BMI < 25 kg/m², insulin sensitive (HOMA-Insuline Resistance (IR) < 2.3), age 40-65
  • Obese groups: BMI > 30 kg/m², presence or absence of type 2 diabetes based on use of glucose lowering medication or HbA1c > 6.5%, age 40-65

Exclusion criteria

  • presence of a history of heart, lung or kidney disease and/or presence of endocrine anomalies. Use of beta-blockade medication.

Treatment and study plan

adipose tissue sampling

Other

adipose tissue (subcutaneous and visceral adipose tissue) sampling during abdominal surgery and phenotype determination

Primary outcomes

  1. Glycerol release by mature adipocytes, isolated from subcutaneous and visceral adipose tissue, upon stimulation with isoprenalin or ANP (ex vivo)

    Time frame: day 1

    Investigation of concentration effect of ISO/ANP on lipolysis (glycerol release) by mature adipocytes isolated from adipose tissue biopsies, glycerol release is measured in the incubation medium following a 3 hour incubation period. Measured for adipose tissue (subcutaneous and visceral adipose tissue) of both lean and obese subjects

  2. ANP receptor expression profiles on mRNA and protein level in both adipose tissue depots for both lean and obese subjects.

    Time frame: day 1

    Receptor expression determination in order to clarify the underlying mechanism responsible for possible differences in lipolytic responses.

  3. Adipose tissue inflammation

    Time frame: day 1

    Adipose tissue inflammation (by means of FACS analysis) and its relation to insulin sensitivity and adipose tissue function in lean, obese and obese diabetics subjects.

Secondary outcomes

  1. Body composition

    Time frame: day 1

    Body composition (body fath percentage), measured by BIA

  2. BMI (kg/m²)

    Time frame: day 1

  3. body height (m)

    Time frame: day 1

  4. weight (kg)

    Time frame: day 1

  5. hip circumference (cm)

    Time frame: Day 1

  6. waist (cm)

    Time frame: Day 1

  7. blood glucose

    Time frame: day 1

  8. blood insuline

    Time frame: day 1

  9. blood FFA

    Time frame: day 1

  10. blood triglycerides

    Time frame: day 1

  11. blood glycated hemoglobin

    Time frame: day 1

  12. blood ANP

    Time frame: day 1

    fasting blood sample to determine blood glucose, insulin, FFA, , glycated hemoglobin and ANP

  13. blood pressure (mmHg)

    Time frame: Day 1

  14. Concomitant medication

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Jessa Hospital

Registry information

Official study title

Atrial Natriuretic Peptide (ANP)-Induced Lipid Mobilization Regulation in Different Adipose Tissue Depots of Obese Subjects

Acronym: ERLO

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 6, 2015
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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