Postprandial Gut Hormone Responses in Patients With Type 1 Diabetes Mellitus
Primary Purpose
type1diabetes, Hunger, Obesity
Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Standardized test meal
Sponsored by
About this trial
This is an interventional basic science trial for type1diabetes
Eligibility Criteria
Inclusion Criteria:
- Type 1 diabetes
- BMI >30 kg/m2 for the obese groups
Exclusion Criteria:
- Diabetic neuropathy
- Malignancy
Sites / Locations
- Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
Lean patients with type 1 diabetes
Obese patients with type 1 diabetes
Lean healthy control subjects
Obese healthy control subjects
Arm Description
Test meal consumed within 10 minutes
Test meal consumed within 10 minutes
Test meal consumed within 10 minutes
Test meal consumed within 10 minutes
Outcomes
Primary Outcome Measures
Gut peptide hormone responses
Postprandial responses of ghrelin, PYY, GLP-1, Glicentin, Oxyntomodulin measured as area under the curve (AUC)
Secondary Outcome Measures
Meal induced thermogenesis
Change in basal metabolic rate after meal consumption as assessed by indirect calorimetry
Full Information
NCT ID
NCT04430946
First Posted
June 11, 2020
Last Updated
June 6, 2022
Sponsor
National and Kapodistrian University of Athens
1. Study Identification
Unique Protocol Identification Number
NCT04430946
Brief Title
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
type1diabetes, Hunger, Obesity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lean patients with type 1 diabetes
Arm Type
Experimental
Arm Description
Test meal consumed within 10 minutes
Arm Title
Obese patients with type 1 diabetes
Arm Type
Experimental
Arm Description
Test meal consumed within 10 minutes
Arm Title
Lean healthy control subjects
Arm Type
Active Comparator
Arm Description
Test meal consumed within 10 minutes
Arm Title
Obese healthy control subjects
Arm Type
Active Comparator
Arm Description
Test meal consumed within 10 minutes
Intervention Type
Diagnostic Test
Intervention Name(s)
Standardized test meal
Intervention Description
A test meal of ~700 kcal consisting of protein and fat will be consumed within 10 minutes
Primary Outcome Measure Information:
Title
Gut peptide hormone responses
Description
Postprandial responses of ghrelin, PYY, GLP-1, Glicentin, Oxyntomodulin measured as area under the curve (AUC)
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Meal induced thermogenesis
Description
Change in basal metabolic rate after meal consumption as assessed by indirect calorimetry
Time Frame
3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Type 1 diabetes
BMI >30 kg/m2 for the obese groups
Exclusion Criteria:
Diabetic neuropathy
Malignancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandros Kokkinos
Phone
+302132061248
Email
rjd@otenet.gr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandros Kokkinos
Organizational Affiliation
First Department of Propaedeutic Medicine, Laiko General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandros Kokkinos, MD, PhD
Phone
+302132061248
Email
akokkinos@med.uoa.gr
12. IPD Sharing Statement
Plan to Share IPD
No
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Postprandial Gut Hormone Responses in Patients With Type 1 Diabetes Mellitus
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