Effects of Oral vs Intravenous Glucose Administration on Novel Candidates of Energy Regulation

NCT04888325 | Completed

• 1 other identifier: 284/02-03-2018
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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 hormonal secretion after nutrient intake mediates the metabolic response in order to maintain energy balance. Proglucagon-derived hormones and especially GLP-1 and glucagon are significantly affected by nutrient intake and by energy balance. Despite the extensive information about GLP-1 and glucagon, it remains unclear whether other proglucagon-derived hormones are regulated by nutrition or by energy status i.e. obesity or type 2 diabetes. Similarly, secretion of activins and follistatins, which are both affecting muscle metabolism-growth and consequently energy homeostasis, are reduced in energy deprivation states. However, we do not know whether the circulating profile of these hormones is affected acutely by nutrient intake and whether these changes have acute effects on muscle metabolism. We propose to conduct a non-blinded interventional study evaluating the effects of oral or intravenous glucose intake in the circulating levels of proglucagon-derived hormones, activin A, activin B, follistatin, follistatin-like 3.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

• Changes of the plasma concentrations of Activins

  Area Under the Curve (AUC) of activins A, B, AB

  6 hours

• Changes of the plasma concentrations of Follistatins

  Area Under the Curve (AUC) of follistatin, FSTL-3

  6 hours

Study Arms (2)

Oral glucose

EXPERIMENTAL

ORal glucose consumption 1.25 grams/kg in 200 ml water at time 0 and the same amount again at 3 hours

Other: Oral glucose

Intravenous glucose

EXPERIMENTAL

0% intravenous glucose infusion at a rate of 3.6 ml/kg/h

Other: Intravenous glucose

Interventions

Oral glucose OTHER

Oral glucose consumption (1.25 grams/kg in 200 ml water at time 0 and the same amount again at 3 hours). During the 6-hour observation period infusion of normal saline (NaCL 0,9%) at a rate of 0.83 plus Heparin, 800 IU/h with a priming dose of 1000 IU.

Oral glucose

Intravenous glucose OTHER

10% intravenous glucose infusion at a rate of 3.6 ml/kg/h plus Heparin 800 IU/h with a priming dose of 1000 IU will be administrated for 6 hours. Consumption of 300 ml of water at 0 and 3 hours

Intravenous glucose

Eligibility Criteria

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

You may qualify if:

• Adult (18-65 years of age) men and women

You may not qualify if:

• 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

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (1)

Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine

Athens, 11527, Greece

Location

Related Publications (1)

• Perakakis N, Kokkinos A, Angelidi AM, Tsilingiris D, Gavrieli A, Yannakoulia M, Tentolouris N, Mantzoros CS. Circulating levels of five proglucagon-derived peptides in response to intravenous or oral glucose or lipids and to a mixed-meal in subjects with normal weight, overweight, and obesity. Clin Nutr. 2022 Sep;41(9):1969-1976. doi: 10.1016/j.clnu.2022.07.001. Epub 2022 Jul 19.

  PMID: 35961260 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Glucose; Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Alexandros Kokkinos, MD, PhD

  Medical School, National and Kapodistrian University of Athens, Laiko General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Internal Medicine

Study Record Dates

• First Submitted: May 9, 2021
• First Posted: May 17, 2021
• Study Start: March 2, 2018
• Primary Completion: April 25, 2018
• Study Completion: April 25, 2018
• Last Updated: May 18, 2021

Record last verified: 2021-05

Locations

GR (1)