Clinical trial NCT04430946: Postprandial Gut Hormone Responses in Patients With Type 1 Diabetes Mellitus
Official title: Comparison of Postpradial Gut Hormone and Metabolic Responses Between Patients With Type 1 Diabetes Mellitus and Healthy Controls
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: type1diabetes
Hunger
Obesity
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Diabetic neuropathy
* Malignancy

Primary outcomes:
measure: Gut peptide hormone responses
timeFrame: 3 hours
Secondary outcomes:
measure: Meal induced thermogenesis
timeFrame: 3 hours
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine
Study officials:
affiliation: First Department of Propaedeutic Medicine, Laiko General Hospital
name: Alexandros Kokkinos
role: PRINCIPAL_INVESTIGATOR
References: