Postprandial Gut Hormone Responses in Patients With Type 1 Diabetes Mellitus

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Hunger; type1diabetes
• Intervention / Treatment: Diagnostic test: Standardized test meal

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandros Kokkinos; Phone Number: +302132061248; Email: rjd@otenet.gr

Study Locations

• Greece
  • Athens, Greece, 11527
    • Recruiting
    • Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Type 1 diabetes
• BMI >30 kg/m2 for the obese groups

Exclusion Criteria:

• Diabetic neuropathy
• Malignancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lean patients with type 1 diabetes; Test meal consumed within 10 minutes	Diagnostic test: Standardized test meal; A test meal of ~700 kcal consisting of protein and fat will be consumed within 10 minutes
EXPERIMENTAL: Obese patients with type 1 diabetes; Test meal consumed within 10 minutes	Diagnostic test: Standardized test meal; A test meal of ~700 kcal consisting of protein and fat will be consumed within 10 minutes
ACTIVE_COMPARATOR: Lean healthy control subjects; Test meal consumed within 10 minutes	Diagnostic test: Standardized test meal; A test meal of ~700 kcal consisting of protein and fat will be consumed within 10 minutes
ACTIVE_COMPARATOR: Obese healthy control subjects; Test meal consumed within 10 minutes	Diagnostic test: Standardized test meal; A test meal of ~700 kcal consisting of protein and fat will be consumed within 10 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut peptide hormone responses	Postprandial responses of ghrelin, PYY, GLP-1, Glicentin, Oxyntomodulin measured as area under the curve (AUC)	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Meal induced thermogenesis	Change in basal metabolic rate after meal consumption as assessed by indirect calorimetry	3 hours

Collaborators and Investigators

• Sponsor: National and Kapodistrian University of Athens
• Investigators: Principal Investigator: Alexandros Kokkinos, First Department of Propaedeutic Medicine, Laiko General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 25, 2020
• Primary Completion (ANTICIPATED): December 30, 2022
• Study Completion (ANTICIPATED): December 30, 2023

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (ACTUAL): June 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: GutT1DM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No