Status:
COMPLETED
Effects of Oral vs Intravenous Glucose Administration on Novel Candidates of Energy Regulation
Lead Sponsor:
National and Kapodistrian University of Athens
Collaborating Sponsors:
Harvard Medical School (HMS and HSDM)
Conditions:
Overweight and Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Energy regulation in humans is controlled through complicated mechanisms involving among others hormones secreted from different tissues, such as gut, muscle and adipose tissue. Specifically, the horm...
Detailed Description
Screening Visit: Potential subjects will present for a study screening visit in the study site. A written informed consent will be obtained by a study physician at the screening visit. Potential subje...
Eligibility Criteria
Inclusion
- Adult (18-65 years of age) men and women
Exclusion
- Subjects with a history of any illness, other than obesity, that may affect insulin sensitivity (anemia, infectious diseases, renal or hepatic failure, uncontrolled hypertension, cancer, lymphoma, chronic inflammatory conditions such as inflammatory bowel disease and rheumatoid arthritis, states of cortisol or growth hormone excess, alcoholism or drug abuse, and eating disorders).
- History of diabetes mellitus.
- Subjects taking any medications that are known to influence glucose metabolism such as glucocorticoids will also be excluded. We will screen for these conditions by means of a detailed history and review of systems and physical examination (see below).
- Subjects taking any medications known to affect lipids such as statins will also be excluded. We will screen for these similar to above.
- Cholesterol greater or equal to 250 mg/dL and/or triglyceride levels greater than 500 mg/dL at the time of screening, as determined by laboratory testing.
- Subjects who have a known history of anaphylaxis or anaphylactoid-like reactions or who have a known hypersensitivity to anesthetic agents such as Lidocaine or Marcaine will be excluded from the study.
- Hypersensitivity to fat emulsion or any component of the formulation; severe egg or legume (soybean) allergies; pathologic hyperlipidemia, lipoid nephrosis, acute pancreatitis associated with hyperlipemia.
- Hypersensitivity to heparin or any component of the formulation
- Severe thrombocytopenia, uncontrolled active bleeding, disseminated intravascular coagulation (DIC); suspected intracranial hemorrhage.
- Subjects with a history of bleeding dyscrasia, poor wound healing or any medical condition precluding supine position will be excluded from the study.
- Unable to follow study protocol or any condition that in the opinion of the investigator makes the subject unsuitable for the study.
- Pregnancy
Key Trial Info
Start Date :
March 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2018
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04888325
Start Date
March 2 2018
End Date
April 25 2018
Last Update
May 18 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine
Athens, Greece, 11527