Comparison of Postpradial Gut Hormone and Metabolic Responses Between Patients With Type 1 Diabetes Mellitus and Healthy Controls
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Gut peptide hormone responses
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Type 1 diabetes
- •BMI >30 kg/m2 for the obese groups
Exclusion Criteria
- •Diabetic neuropathy
- •Malignancy
Arms & Interventions
Lean patients with type 1 diabetes
Test meal consumed within 10 minutes
Intervention: Standardized test meal (Diagnostic Test)
Obese patients with type 1 diabetes
Test meal consumed within 10 minutes
Intervention: Standardized test meal (Diagnostic Test)
Lean healthy control subjects
Test meal consumed within 10 minutes
Intervention: Standardized test meal (Diagnostic Test)
Obese healthy control subjects
Test meal consumed within 10 minutes
Intervention: Standardized test meal (Diagnostic Test)
Outcomes
Primary Outcomes
Gut peptide hormone responses
Time Frame: 3 hours
Postprandial responses of ghrelin, PYY, GLP-1, Glicentin, Oxyntomodulin measured as area under the curve (AUC)
Secondary Outcomes
- Meal induced thermogenesis(3 hours)
Investigators
Alexandros Kokkinos
Associate Professor in Internal Medicine
National and Kapodistrian University of Athens