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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04037410
Other study ID # 2. Tenv & cancer patient
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 10, 2019
Est. completion date May 31, 2019

Study information

Verified date July 2019
Source University of Thessaly
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators aimed to retrospectively identify the association between the thermogenic capacity of white adipocytes and the environmental temperature, in cancer patients.


Description:

Obesity is characterized by excessive white adipose tissue (WAT) that increases risk for disease. About 700 million adults are obese worldwide, designating the need of reducing excessive WAT in humans and subsequently the risk for disease. For this reason, previous research focused on the thermogenic capacity of white adipocytes in response to cold exposure. Cold exposure represents a main stimulus for increased thermogenic capacity in human white adipocytes, which may have an impact on body weight loss and subsequently on obesity phenomenon.

In a cohort of 202 cancer patients (male=126), who undertook a Positron Emission Tomography (PET/CT), we retrospectively investigated the association between Tenv and thermogenic capacity of subcutaneous WAT (dorsolumbar region near vertebrae L3 and abdominal region). These patients undertook a PET/CT examination in order to define their disease status. They were given instructions in advance to refrain from smoking, exercise and excessive muscle stressors 24-hour prior to their examination. On the day of the measurements they advised to transport themselves by car to the PET/CT Laboratory between 08:00 am to 12 pm, following at least a 6-hour fasting. Patients were first injected an appropriate dose of 18F-FDG (based on their body weight) and then they were remained in a sitting relaxed position within a quiet room of 22-24°C for 60 minutes. Following this period, patients undertook the PET/CT examination, which included on average eight bed positions, while four minutes scanning per bed position was used.

PET/CT imaging analysis for WAT activity (dorsolumbar region near vertebrae L3 and abdominal region) was performed by two independent trained physicians, using previous methodology.


Recruitment information / eligibility

Status Completed
Enrollment 202
Est. completion date May 31, 2019
Est. primary completion date May 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Cancer patients who undertook a PET/CT examination independently of their disease status

Exclusion Criteria:

- Examinations prior to 2016

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Greece Petros Dinas Tríkala Thessaly

Sponsors (1)

Lead Sponsor Collaborator
Petros Dinas

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of thermogenic capacity of white adipocytes Thermogenic capacity of white adipocytes was measured via Positron Emission Tomography/computed tomography (PET/CT) device, unit of measurement: Standardized Uptake Value (SUV) The SUV of white adipocytes for each patient was measured once via the PET/CT software between 10-30 May 2019.
Primary Environmental temperature The daily environmental temperature was obtained in degrees Celsius for the period 1-1-2016 to 30-4-2019. The daily environmental temperature was obtained from Weather Underground (www.wunderground.com) on the 10th May 2019
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