Short-term Effects of Carbohydrate-restricted Diet on Glycemic and Metabolic Control Among Children and Adolescent With Type 1 Diabetes Mellitus
NCT ID: NCT06699485
Last Updated: 2024-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
25 participants
INTERVENTIONAL
2025-01-01
2025-07-31
Brief Summary
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There is a need to strengthen some of the T1DM management aspects as dietary intervention in order to achieve better glycemic and metabolic control.
The international society for pediatric and adolescent diabetes (ISPAD) recommend that children and adolescents with T1DM have about 50% of their total daily caloric requirement from carbohydrates. However, an alternative approach is emerging in recent years. The use of low-carbohydrate diet is suggested to reduce postprandial hyperglycemia and glycemic variability and lower the required insulin.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Group 1
Children and adolescents aged 10 - 18 years, diagnosed with T1DM for at least 1 year
Low carb diet
Low-carbohydrate diet contains (\<26% carbohydrates) or less than 130 g/d
Interventions
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Low carb diet
Low-carbohydrate diet contains (\<26% carbohydrates) or less than 130 g/d
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
10 Years
18 Years
ALL
Yes
Sponsors
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Sohag University
OTHER
Responsible Party
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Hadeer Soliman Kamaleldin
Resident of pediatric department
Central Contacts
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References
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Bravata DM, Sanders L, Huang J, Krumholz HM, Olkin I, Gardner CD, Bravata DM. Efficacy and safety of low-carbohydrate diets: a systematic review. JAMA. 2003 Apr 9;289(14):1837-50. doi: 10.1001/jama.289.14.1837.
Mitsui Y, Kuroda A, Ishizu M, Mori H, Kurahashi K, Kondo T, Yoshida S, Akehi Y, Aihara KI, Endo I, Abe M, Matsuhisa M. Basal insulin requirement in patients with type 1 diabetes depends on the age and body mass index. J Diabetes Investig. 2022 Feb;13(2):292-298. doi: 10.1111/jdi.13547. Epub 2021 May 3.
Kuroda A, Yasuda T, Takahara M, Sakamoto F, Kasami R, Miyashita K, Yoshida S, Kondo E, Aihara K, Endo I, Matsuoka TA, Kaneto H, Matsumoto T, Shimomura I, Matsuhisa M. Carbohydrate-to-insulin ratio is estimated from 300-400 divided by total daily insulin dose in type 1 diabetes patients who use the insulin pump. Diabetes Technol Ther. 2012 Nov;14(11):1077-80. doi: 10.1089/dia.2012.0109.
Abraham MB, Jones TW, Naranjo D, Karges B, Oduwole A, Tauschmann M, Maahs DM. ISPAD Clinical Practice Consensus Guidelines 2018: Assessment and management of hypoglycemia in children and adolescents with diabetes. Pediatr Diabetes. 2018 Oct;19 Suppl 27:178-192. doi: 10.1111/pedi.12698. No abstract available.
Other Identifiers
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Soh-Med-15-10-1MS
Identifier Type: -
Identifier Source: org_study_id
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