The clinical usefulness of a new diet for effective weight loss and metabolic improvement in obese patients: a prospective follow-up study on the usefulness of a relative low carbohydrate and low insulin diet in patients with BMI 35 and more kg/m2.

Prospective follow-up study of the usefulness of a relatively low-carbohydrate insulin diet/high-protein, fat diet - Low Glycemic- and Low Insulin- Diet

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000053513

Enrollment

Registered

2024-04-01

Start date

2024-04-01

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

Obesity

Interventions

Standard low-energy diet (25 kcal/ kg standard body weight/m2) Low glycemic/low insulin diet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age: 20 to 70 years old men and women Patients with a BMI of 30 kg/m2 or more T2DM patients without severe cardiovascular, hepatic or renal impairments

Exclusion criteria

Exclusion criteria: Obese type 2 diabetic patients using either insulin or GLP-1 receptor agonists at the time of entry

Design outcomes

Primary

Measure	Time frame
The following data will be measured. Weight loss, fasting blood glucose, HbA1c, insulin secretion (HOMA-beta), insulin resistance (HOMA-R), cardiovascular risk factors (BP, LDL-C, TG, HDL-C), visceral fat mass, fatty liver variables, TG, Apo B100, Apo B 48 values measured under a meal tolerance test, and the effects of the intervention test on dietary behavior change will be evaluated. Measurements were taken before start, and after 3, 6 and 12 months.	—

Measure

Time frame

The following data will be measured. Weight loss, fasting blood glucose, HbA1c, insulin secretion (HOMA-beta), insulin resistance (HOMA-R), cardiovascular risk factors (BP, LDL-C, TG, HDL-C), visceral fat mass, fatty liver variables, TG, Apo B100, Apo B 48 values measured under a meal tolerance test, and the effects of the intervention test on dietary behavior change will be evaluated. Measurements were taken before start, and after 3, 6 and 12 months.

—

Countries

Japan

Contacts

Public ContactYukako Yamamoto

Hospital Diabetes and Endcrinorogy

yukako.911426@gmail.com0775638866

Outcome results

None listed

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