Genetic Variation in CLTCL1 and Whole-body Glucose Control

NCT03998111 | Completed

• 1 other identifier: EP 17/18 252
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Maintaining stable blood glucose concentrations after eating has important implications for health. Individuals who are better able to maintain stable blood glucose concentrations after consuming carbohydrate have a lower risk of mortality from cardiovascular disease. Muscle is the primary tissue for glucose disposal following a meal, and responsiveness of this tissue to insulin is dictated by GLUT4 translocation to the muscle cell membrane. Clathrin heavy chain isoform 22 (CHC22) is a protein that plays a key role in intracellular GLUT4 action, and it may play an important role in whole-body glucose control. Genetic variation in the gene which codes for CHC22 may be able to explain differences in glucose control at the whole-body level.

Conditions

Glucose Control

Keywords

Glucose; Genetic variation; CHC22; CLTCL1

Outcome Measures

Primary Outcomes (2)

• Plasma glucose incremental area under the curve (CHC22 genotype)

  Plasma glucose samples will be obtained throughout the 2-hour postprandial period and the incremental area under the curve will be calculated, this will be grouped by CHC22 genotype.

  2 hours

• Peak plasma glucose (CHC22 genotype)

  Plasma glucose samples will be obtained throughout the 2-hour postprandial period and the peak glucose concentration will be measured, this will be grouped by CHC22 genotype.

  2 hours

Secondary Outcomes (5)

• Fasting plasma glucose concentrations (CHC22 genotype)

  2 hours

• Plasma glucose incremental area under the curve (other genotypes)

  2 hours

• Fasting plasma glucose concentrations (other genotypes)

  2 hours

• Matsuda insulin sensitivity index

  2 hours

• Homeostasis model of insulin resistance

  2 hours

Study Arms (1)

Trial

EXPERIMENTAL

Participants will undergo one trial visit where they will ingest an oral glucose load diluted in solution (oral glucose tolerance test) and blood samples will be measured over the following 2-hours. The buffy coat layer from the baseline sample will be obtained to extract DNA.

Diagnostic Test: Oral glucose tolerance test

Interventions

Oral glucose tolerance test DIAGNOSTIC_TEST

Participants will ingest 75 g anhydrous glucose dissolved in water and the blood responses will be measured over the following 2-hours using a venous cannula.

Trial

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index between 18.5-29.9 kg/m\^2
• Aged 18-65 years
• Able and willing to provide informed consent and safely comply with study procedures

You may not qualify if:

• Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias
• Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes)
• Any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment
• Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker)

Sponsors & Collaborators

• Javier Gonzalez: lead
• University College, London: collaborator

Study Sites (1)

Department for Health, University of Bath

Bath, BA2 7AY, United Kingdom

Location

MeSH Terms

Interventions

Glucose Tolerance Test

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 26, 2019
• Study Start: October 1, 2018
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-05

Locations

GB (1)