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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04430946
Other study ID # GutT1DM
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 25, 2020
Est. completion date December 30, 2023

Study information

Verified date June 2022
Source National and Kapodistrian University of Athens
Contact Alexandros Kokkinos
Phone +302132061248
Email rjd@otenet.gr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will compare the postprandial responses to a test meal between subjects with type 1 diabetes and healthy control subjects, in terms of gut hormone levels, meal induced thermogenesis, hunger and satiety perception, as well as futher metabolic parameters.


Description:

Aim of the study To compare the acute effect of the consumption of a test meal on satiety, gastrointestinal hormones' response, post-meal thermogenesis, and further metabolic parameters in lean patients with type 1 diabetes mellitus (T1DM), obese patients with T1DM, and healthy lean and obese controls. Study subjects: Four groups of participants will be recruited, consisting of 15 lean healthy subjects (BMI <25 kg/m2), 15 obese healthy subjects, 15 lean patients with T1DM (BMI <25 kg/m2), and 15 obese patients with T1DM (BMI ≥ 30kg/m2). Groups will be matched for age and sex. Healthy volunteers will be recruited from the community, and diabetic individuals from our diabetes clinic. Eligibility criteria will include 18-65 years of age, no use of medications affecting appetite and stable weight (no fluctuations exceeding 5 kg the last 3 months. Methods: Demographic data and anthropometric measurements will be collected on the day of visit. Fasting blood samples will be collected for measurement of plasma glucose, insulin, triglycerides, GIP, GLP-1, PYY (total), ghrelin (total). VAS for hunger and satiety will be completed in the fasting state. Participants will then consume a test meal of ~700 kcal consisting of protein and fat (no carbohydrates) within 10 minutes. Blood samples will be drawn and VAS scales completed postprandially at 30, 60, 90, 120, 150, 180 min. RMR measurements using indirect calorimetry will be performed in the fasting state, 1 hour and 3 hours postprandially to assess meal induced thermogenesis. Postprandial responses for these parameters will be assessed as area under the curve (AUC). Patients with T1DM treated with basal- bolus insulin therapy will receive their regular basal insulin dose and patients on an insulin pump will be kept on their basal rate of insulin infusion. In case of fasting hyperglycemia, the session will be canceled. Postrpandial glucose excursion will be treated with fast acting insulin.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 30, 2023
Est. primary completion date December 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Type 1 diabetes - BMI >30 kg/m2 for the obese groups Exclusion Criteria: - Diabetic neuropathy - Malignancy

Study Design


Intervention

Diagnostic Test:
Standardized test meal
A test meal of ~700 kcal consisting of protein and fat will be consumed within 10 minutes

Locations

Country Name City State
Greece Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine Athens

Sponsors (1)

Lead Sponsor Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gut peptide hormone responses Postprandial responses of ghrelin, PYY, GLP-1, Glicentin, Oxyntomodulin measured as area under the curve (AUC) 3 hours
Secondary Meal induced thermogenesis Change in basal metabolic rate after meal consumption as assessed by indirect calorimetry 3 hours
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