Postprandial Gut Hormone Responses in Patients With Type 1 Diabetes Mellitus

Obesity Clinical Trial

Official title:

Comparison of Postpradial Gut Hormone and Metabolic Responses Between Patients With Type 1 Diabetes Mellitus and Healthy Controls

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04430946
• Other study ID #: GutT1DM
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hunger
• Obesity
• type1diabetes

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