Postprandial Gut Hormone Responses in Patients With Type 1 Diabetes Mellitus

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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type1diabetes, Hunger, Obesity

Intervention / Treatment
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* Diagnostic Test: Standardized test meal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes BMI >30 kg/m2 for the obese groups Exclusion Criteria: Diabetic neuropathy Malignancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lean patients with type 1 diabetes<br>Test meal consumed within 10 minutes | Diagnostic Test: Standardized test meal<br>* A test meal of  700 kcal consisting of protein and fat will be consumed within 10 minutes<br>|
| Experimental: Obese patients with type 1 diabetes<br>Test meal consumed within 10 minutes | Diagnostic Test: Standardized test meal<br>* A test meal of  700 kcal consisting of protein and fat will be consumed within 10 minutes<br>|
| Active Comparator: Lean healthy control subjects<br>Test meal consumed within 10 minutes | Diagnostic Test: Standardized test meal<br>* A test meal of  700 kcal consisting of protein and fat will be consumed within 10 minutes<br>|
| Active Comparator: Obese healthy control subjects<br>Test meal consumed within 10 minutes | Diagnostic Test: Standardized test meal<br>* A test meal of  700 kcal consisting of protein and fat will be consumed within 10 minutes<br>|

What is the study measuring?
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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 |