Overweight and ObesityNCT04888325
Effects of Oral vs Intravenous Glucose Administration on Novel Candidates of Energy Regulation
A study testing Oral glucose and Intravenous glucose in people with Overweight and Obesity, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Oral glucose and Intravenous glucose
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteGreece
- Study dates
- 2 Mar 2018to 25 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (18-65 years of age) men and women
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine
Athens, 11527
About this study
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.
Read the 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 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).
- Conditions
- Overweight and Obesity
- Being tested
- Oral glucose, Intravenous glucose
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucoseOther
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.
Intravenous glucoseOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Oral glucose |
| Intravenous glucose | Experimental | 0% intravenous glucose infusion at a rate of 3.6 ml/kg/h Receives: Other: Intravenous glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the plasma concentrations of Activins
Area Under the Curve (AUC) of activins A, B, AB
Measured: 6 hours
Changes of the plasma concentrations of Follistatins
Area Under the Curve (AUC) of follistatin, FSTL-3
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start2 Mar 2018
- Primary completion25 Apr 2018
- Study completion25 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Alexandros Kokkinos, National and Kapodistrian University of Athens
- Investigators
- Alexandros Kokkinos, MD, PhD, Principal investigator, Medical School, National and Kapodistrian University of Athens, Laiko General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888325
- Sponsor's protocol ID
- 284/02-03-2018
- Status last verified
- May 2021
- First submitted
- 9 May 2021
- Last updated
- 18 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35961260
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral vs Intravenous Glucose Administration on Novel Candidates of Energy Regulation
- ClinicalTrials.gov ID
- NCT04888325
- Acronym / sponsor ID
- 284/02-03-2018
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- 25 Apr 2018 (actual)
- Study completion
- 25 Apr 2018 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral glucose | Experimental | Other: Oral glucoseORal glucose consumption 1.25 grams/kg in 200 ml water at time 0 and the same amount again at 3 hours |
| Intravenous glucose | Experimental | Other: Intravenous glucose0% intravenous glucose infusion at a rate of 3.6 ml/kg/h |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult (18-65 years of age) men and women
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral glucoseOral 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. | Other | Oral glucose |
| Intravenous glucose10% 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 | Other | Intravenous glucose |
Primary outcome
Changes of the plasma concentrations of Activins
Time frame: 6 hours
Area Under the Curve (AUC) of activins A, B, AB
Changes of the plasma concentrations of Follistatins
Time frame: 6 hours
Area Under the Curve (AUC) of follistatin, FSTL-3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Derived from this study: PubMed 35961260Perakakis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandros Kokkinos, MD, PhD principal investigator
Medical School, National and Kapodistrian University of Athens, Laiko General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral glucose and Intravenous glucose in people with Overweight and Obesity, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of the plasma concentrations of Activins (time frame: 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04888325, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.