Sahoor Meal Regimen for Patients With Type1 Diabetes

NCT04864483 | Completed DMC

• 1 other identifier: RJ20/446/J,
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

To examine effects of two approaches to sahoor meal consumption during Ramadan on blood sugar control and incidence of early day hypoglycemic episodes requring the discontinuation of fasting.

Conditions

Type1diabetes; Fasting Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Incidence of early day hypoglycemia

  To determine if taking insulin dose suhoor meal 90 minutes before dawn plus a predawn high protein snack is associated with less rates of hypoglycemia -(we will consider glucose level of 70 mg/dl ( 3.9 mmol/l) and below as the level of hypoglycemia - compared to taking insulin dose suhoor meal 15-30 minutes before dawn during fasting Ramadan in patietnts with T1DM on MDI or insulin pump

  1 month

Secondary Outcomes (6)

• number of days fasting discontinued

  1 month

• Hyperglycemia incidence during fasting

  1 month

• Blood sugar control

  1 month

• Incidence of complications

  1 month

• Glucose variability

  1 month

Study Arms (2)

Early sahoor with predawn snack

EXPERIMENTAL

To take the Sahoor meal 1:30-2 hours before dawn with insulin dose then a pre-dawn snack with no insulin (Sahoor is the latest meal before starting the fast at dawn during the month of Ramadan. The intervention is meal timing in relation to start of fast and does not involve any medications).

Other: Meal timing in relation to time of starting the fast

Late Sahoor meal (within 30 minjted of dawn) with insulin dose

EXPERIMENTAL

To take sahoor meal as late as possi le with usual insulin dose (Sahoor is the latest meal before starting the fast at dawn during the month of Ramadan. The intervention is meal timing in relation to start of fast and does not involve any medications).

Other: Meal timing in relation to time of starting the fast

Interventions

Meal timing in relation to time of starting the fast OTHER

as described

Early sahoor with predawn snack; Late Sahoor meal (within 30 minjted of dawn) with insulin dose

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• DM type 1
• Age \> 14 years
• Diagnosis of type 1 DM of more than 6 months.
• Committed to do SMBG or on CGM
• On Multiple Daily Injections or insulin pumps
• On carbohydrate counting for meal dosing
• Have previously fasted Ramadan
• Are willing to fast this year
• Well educated about requirements for fasting Ramadan

You may not qualify if:

• Cognitive impairment or learning disability
• Renal and hepatic impairment
• Adrenal insufficiency
• Pregnancy
• Alcohol consumption
• Any diagnosed psychiatric disease

Sponsors & Collaborators

• King Abdullah International Medical Research Center: lead

Study Sites (1)

KingAbullahIMRC

Jeddah, Western, 21423, Saudi Arabia

Location

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Reem M Alamoudi

  King Abdullah International Medical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Randomized cross over design

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 29, 2021
• Study Start: March 21, 2021
• Primary Completion: June 27, 2021
• Study Completion: August 30, 2021
• Last Updated: April 11, 2022

Record last verified: 2022-04

Locations

SA (1)