Postprandial Gut Hormone Responses in Patients With Type 1 Diabetes Mellitus

NCT ID: NCT04430946

Last Updated: 2022-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-25
• Study Completion Date: 2023-12-30

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.

Conditions

type1diabetes; Hunger; Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Lean patients with type 1 diabetes

Test meal consumed within 10 minutes

Group Type: EXPERIMENTAL

Standardized test meal

Intervention Type: DIAGNOSTIC_TEST

A test meal of \~700 kcal consisting of protein and fat will be consumed within 10 minutes

Obese patients with type 1 diabetes

Test meal consumed within 10 minutes

Group Type: EXPERIMENTAL

Standardized test meal

Intervention Type: DIAGNOSTIC_TEST

A test meal of \~700 kcal consisting of protein and fat will be consumed within 10 minutes

Lean healthy control subjects

Test meal consumed within 10 minutes

Group Type: ACTIVE_COMPARATOR

Standardized test meal

Intervention Type: DIAGNOSTIC_TEST

A test meal of \~700 kcal consisting of protein and fat will be consumed within 10 minutes

Obese healthy control subjects

Test meal consumed within 10 minutes

Group Type: ACTIVE_COMPARATOR

Standardized test meal

Intervention Type: DIAGNOSTIC_TEST

A test meal of \~700 kcal consisting of protein and fat will be consumed within 10 minutes

Interventions

Standardized test meal

A test meal of \~700 kcal consisting of protein and fat will be consumed within 10 minutes

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Diabetic neuropathy
• Malignancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National and Kapodistrian University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Alexandros Kokkinos

Associate Professor in Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandros Kokkinos

Role: PRINCIPAL_INVESTIGATOR

First Department of Propaedeutic Medicine, Laiko General Hospital

Locations

Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine

Athens, , Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Alexandros Kokkinos

Role: CONTACT

rjd@otenet.gr

+302132061248

Facility Contacts

Alexandros Kokkinos, MD, PhD

Role: primary

akokkinos@med.uoa.gr

+302132061248

References

Boutari C, Stefanakis K, Simati S, Guatibonza-Garcia V, Valenzuela-Vallejo L, Anastasiou IA, Connelly MA, Kokkinos A, Mantzoros CS. Circulating total and H-specific GDF15 levels are elevated in subjects with MASLD but not in hyperlipidemic but otherwise metabolically healthy subjects with obesity. Cardiovasc Diabetol. 2024 May 18;23(1):174. doi: 10.1186/s12933-024-02264-5.

Reference Type: DERIVED

PMID: 38762719 (View on PubMed)

Stefanakis K, Kokkinos A, Simati S, Argyrakopoulou G, Konstantinidou SK, Kouvari M, Kumar A, Kalra B, Mantzoros CS. Circulating levels of all proglucagon-derived peptides are differentially regulated postprandially by obesity status and in response to high-fat meals vs. high-carbohydrate meals. Clin Nutr. 2023 Aug;42(8):1369-1378. doi: 10.1016/j.clnu.2023.06.026. Epub 2023 Jun 28.

Reference Type: DERIVED

PMID: 37418844 (View on PubMed)

Other Identifiers

GutT1DM

Identifier Type: -

Identifier Source: org_study_id