An interventional study of Oral glucose and Intravenous glucose in Overweight and Obesity, sponsored by National and Kapodistrian University of Athens. Completed at 1 site in Greece. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-18.
Sponsored by National and Kapodistrian University of Athens · Not applicable, Interventional, and Other
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.
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 subjects will have their medical history obtained and will be examined by a study physician. Vitals will be taken and height, weight, and waist circumference will be measured. Potential subjects will have a screening fingerstick glucose test as a marker of diabetes and blood collected for CBC and basic lipid panel. Menstrual status will be assessed by menstrual history (female subjects only) and women will take a urine pregnancy test and will be excluded from participation if pregnant. Subjects will meet with a registered dietitian.
Visit 1: Subjects will return to the GCRC after a 10-hour overnight fast. In the study site, subjects will have vital signs and anthropometrics measured. All subjects will have one IV line, used to obtain blood samples for insulin, glucose, proglucagon derived hormones and muscle-acting hormones (activin A, activin B, follistatin, follistatin-like 3).
Participants will consume orally glucose 1.25 grams/kg in 200 ml water at time 0 and the same amount again at 3 hours. During the 6-hour period they are also going to receive normal saline (NaCL 0,9%) at a rate of 0.83 plus Heparin, 800 IU/h with a priming dose of 1000 IU.
Blood collection will be obtained from the IV line at 30 min intervals for the first 2 hrs and hourly thereafter.
Visit 2: Subjects will return after a 10-hour overnight visit. Visit 2 will be performed at least 1 week after Visit 1. All subjects will have two IV lines, one for obtaining blood samples for insulin, glucose, proglucagon derived hormones and muscle-acting hormones (activin A, activin B, follistatin, follistatin-like 3) and another one for the intravenous administration of glucose.
Specifically a 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. At time 0 and at 3 hours they will drink 300 ml water to control for any effects of gastric distension.
Blood collection will be obtained from the IV line at 30 min intervals for the first 2 hrs and hourly thereafter.
Each blood draw will be 15 ml (5 ml in EDTA tubes with aprotinin and 10 ml in serum tubes).
3,670 studies on the registry are indexed under Overweight; 850 are open to participants now.
This study's enrollment of 6 is below the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →National and Kapodistrian University of Athens is the lead sponsor of 168 studies on the registry; 50 are open to participants now.
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Adult (18-65 years of age) men and women
Exclusion Criteria:
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
0% intravenous glucose infusion at a rate of 3.6 ml/kg/h
Other: Intravenous glucose
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.
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
Changes of the plasma concentrations of Activins
Area Under the Curve (AUC) of activins A, B, AB
Time frame: 6 hours
Changes of the plasma concentrations of Follistatins
Area Under the Curve (AUC) of follistatin, FSTL-3
Time frame: 6 hours
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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National and Kapodistrian University of Athens