Endocrine Regulation of Lipolysis in Obesity and Diabetes

NCT02598544 | Completed

• 1 other identifier: 14.17/REVA14.02
• Study Type: interventional
• Target: 55
• Locations: 2 countries
• Sites: 4

Brief Summary

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.

Conditions

Obesity; Diabetes

Outcome Measures

Primary Outcomes (3)

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

  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

  day 1

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

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

  day 1

• Adipose tissue inflammation

  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.

  day 1

Secondary Outcomes (14)

• Body composition

  day 1

• BMI (kg/m²)

  day 1

• body height (m)

  day 1

• weight (kg)

  day 1

• hip circumference (cm)

  Day 1

Study Arms (3)

lean men

OTHER

Other: adipose tissue sampling

Obese men without type 2 diabetes

OTHER

Other: adipose tissue sampling

Obese men with type 2 diabetes

OTHER

Other: adipose tissue sampling

Interventions

adipose tissue sampling OTHER

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

Obese men with type 2 diabetes; Obese men without type 2 diabetes; lean men

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hasselt University: lead
• Jessa Hospital: collaborator

Study Sites (4)

Hasselt University

Diepenbeek, B-3590, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, B-3600, Belgium

Location

Jessa Ziekenhuis

Hasselt, B-3500, Belgium

Location

Maastricht University

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Dominique Hansen, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Ellen Blaak, prof. dr.

  Maastricht University

  PRINCIPAL INVESTIGATOR

• Kenneth Verboven, drs.

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: November 6, 2015
• Study Start: May 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

BE (3); NL (1)