Diabetes Risk in London and Its Association with Vitamin D by Ethnic Group (DELVE)

NCT06241976 | Completed DMC

• 2 other identifiers: ETH2223-2000G-002602
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to investigate the relationship between vitamin D status and a diabetes risk factor, postprandial glycaemic response in White, South Asian and Black African Caribbean populations in London. The main question\[s\] it aims to answer are:

• Are there differences in postprandial glycaemic response to a sugar water drink or orange juice between White, South Asian and Black African Caribbean people in London?
• Is there a relationship plasma 25(OH)D and the postprandial glycaemic response to a sugar water drink or orange juice consumption?
• What are the knowledge and perceptions of vitamin D intake between White, South Asian and Black African Caribbean people in London?
• Is there a difference in dietary vitamin D intake between the three ethnic groups? Participants will make two visits to the lab, approximately 2.5 hours each. The order of the two drinks will be randomized via Excel Random function. For each visit, the blood sugar levels will be measured at fasting (0) and every 30 minutes up to 2 hours postprandially (5 times total) using a finger prick. At baseline only (visit 1), participants will fill out a knowledge and perception survey, provide a 4-day estimated food diary, provide a 7 ml blood sample via phlebotomy, and have their height, weight and body fat percentage measured.

Conditions

Hyperglycemia, Postprandial; Vitamin D Status

Keywords

Postprandial glycaemic response; Vitamin D; 25(OH)D; Ethnic groups

Outcome Measures

Primary Outcomes (1)

• Postprandial glycaemic response

  Blood glucose concentrations measured using HemoCue glucose analyser (HemoCue Ltd, Angelholm, Sweden) at five time points for each beverage (one visit per beverage)

  Measured at fasted baseline (0 min), +30, +60, +90 and +120 minutes for each beverage

Secondary Outcomes (3)

• Plasma 25(OH)D

  Measured fasted at baseline (0 min) only

• Dietary vitamin D intake

  Four consecutive days recorded between visits 1 and 2 (average 7 days)

• Knowledge and perception of vitamin D

  Measured fasted at baseline (0 min) only

Other Outcomes (8)

• Participant body fat percentage

  Measured fasted at baseline (0 min) only

• Participant body mass index (BMI)

  Measured fasted at baseline (0 min) only

• Plasma parathyroid hormone (PTH)

  Measured fasted at baseline (0 min) only

Study Arms (3)

White Caucasian group

OTHER

Participants from white Caucasian origin

Other: Glucose drink; Other: Pure orange juice

South Asian group

OTHER

Participants from South Asian origin

Other: Glucose drink; Other: Pure orange juice

Black African-Caribbean

OTHER

Participants from Black African-Caribbean origin

Other: Glucose drink; Other: Pure orange juice

Interventions

Glucose drink OTHER

75g glucose in 300 ml water (281 kcal) used for oral glucose tolerance test (OGTT)

Black African-Caribbean; South Asian group; White Caucasian group

Pure orange juice OTHER

300ml pure orange juice (OJ, Tesco 100% Pure Squeezed Orange Juice Smooth containing 129 kcal, 30 g sugar, 0.3 g fibre, 1.8 g protein and 90 mg vitamin C) from Tesco supermarket

Black African-Caribbean; South Asian group; White Caucasian group

Eligibility Criteria

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

You may qualify if:

• Age 18-65 years
• Live in any London Borough
• Participants ethnicity is either White Caucasian, South Asian, or Black African-Caribbean

You may not qualify if:

• Mixed or multiple ethnicities
• Diagnosis of diabetes
• Diagnosis of a digestive system diseases
• Diagnosis of a liver or kidney disease
• Diagnosis of any other chronic diseases
• Diagnosis of any blood clotting disorders
• Are currently pregnant or breastfeeding
• A body mass index (BMI) \<18.5 kg/m2
• Consume alcohol more than 14 units per week
• Regular smoker (one or more cigarettes per day)
• On special diet
• Gluten sensitivity or celiac disease
• Fasting blood glucose ≥ 11 mmol/L

Sponsors & Collaborators

• City, University of London: lead
• Barts & The London NHS Trust: collaborator

Study Sites (1)

City, University of London

London, London, N1 4FE, United Kingdom

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Honglin Dong

  City, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Model Details: Participants will be randomly allocated to the order they receive the two beverages, a glucose drink (G) and pure orange juice (O). All participants will consume both beverages at separate occasions

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: February 5, 2024
• Study Start: July 1, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)