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Impact of carbohydrate and its sources on BMI, visceral fat and non-alcoholic fatty liver in patients with type 2 diabetes

Impact of carbohydrate and its sources on visceral fat and non-alcoholic fatty liver in patients with type 2 diabetes - Impact of carbohydrate ant its sources on visceral fat and fatty liver in diabetes patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000038314
Enrollment
300
Registered
2019-11-01
Start date
2019-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes

Interventions

We treat patients with type 2 diabetes with a moderate low carbohydrate diet over 6 months. We instruct to reduce carbohydrate intake according to patients baseline carbohydrate intake and HbA1c level

Sponsors

Haimoto Clinic
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: New Japanese outpatients with type 2 diabetes and HbA1c levels of 6.5% or above at Haimoto Clinic who do not take any type of oral hypoglycemic agent, insulin or steroid hormone from 3 months before baseline.

Exclusion criteria

Exclusion criteria: Taking any type of oral hypoglycemic agent, insulin or steroid hormone from 3 months before baseline that would impact HbA1c levels; following strict carbohydrate restriction at baseline based on commercial diet therapies such as the Atkins diet; serum creatinine levels greater than 2.0 mg/dl, ketoacidosis, soft drink ketosis, cancer or decompensatory liver cirrhosis and alcoholic fatty liver disease.

Design outcomes

Primary

MeasureTime frame
BMI and visceral fat by CT and CT value in the liver and spleen, macronutrients and carbohydrate sources based on dietary records at baseline and 6 months, and the association of changes in carbohydrate sources with changes in the above parameters.

Secondary

MeasureTime frame
Insulin, HOMA-IR and serum lipid profile at baseline and 6 months later

Countries

Japan

Contacts

Public ContactHajime Haimoto

Haimoto Clinic Department of Internal Medicine

haimoto@gol.com0568-85-0568

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026