NCT04430946

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 25, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

June 7, 2022

Status Verified

June 1, 2022

Enrollment Period

2.3 years

First QC Date

June 11, 2020

Last Update Submit

June 6, 2022

Conditions

type1diabetesHungerObesity

Outcome Measures

Primary Outcomes (1)

  • Gut peptide hormone responses

    Postprandial responses of ghrelin, PYY, GLP-1, Glicentin, Oxyntomodulin measured as area under the curve (AUC)

    3 hours

Secondary Outcomes (1)

  • Meal induced thermogenesis

    3 hours

Study Arms (4)

Lean patients with type 1 diabetes

EXPERIMENTAL

Test meal consumed within 10 minutes

Diagnostic Test: Standardized test meal

Obese patients with type 1 diabetes

EXPERIMENTAL

Test meal consumed within 10 minutes

Diagnostic Test: Standardized test meal

Lean healthy control subjects

ACTIVE COMPARATOR

Test meal consumed within 10 minutes

Diagnostic Test: Standardized test meal

Obese healthy control subjects

ACTIVE COMPARATOR

Test meal consumed within 10 minutes

Diagnostic Test: Standardized test meal

Interventions

Standardized test mealDIAGNOSTIC_TEST

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

Lean healthy control subjectsLean patients with type 1 diabetesObese healthy control subjectsObese patients with type 1 diabetes

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Diabetic neuropathy
  • Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Athens, 11527, Greece

RECRUITING

Related Publications (2)

  • 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.

    PMID: 38762719DERIVED

  • 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.

    PMID: 37418844DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alexandros Kokkinos

    First Department of Propaedeutic Medicine, Laiko General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandros Kokkinos

CONTACT

+302132061248rjd@otenet.gr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Internal Medicine

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 16, 2020

Study Start

August 25, 2020

Primary Completion

December 30, 2022

Study Completion

December 30, 2023

Last Updated

June 7, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)