Impact of Sorghum Rice on Beta-Cell Function and Insulin Resistance in Prediabetes

NCT07298304 | Completed DMC

• 1 other identifier: 52/EC/KEPK/FKUA/2022
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Prediabetes is a condition where blood sugar levels are higher than normal but not yet high enough to be diagnosed as diabetes. Without lifestyle changes, people with prediabetes often develop type 2 diabetes, a serious disease affecting millions worldwide. Diet plays a crucial role in preventing this progression, and replacing refined grains like white rice with whole grains may help improve metabolic health. This study investigated whether eating sorghum rice-a nutritious whole grain rich in fiber and natural antioxidants-could affect leptin levels in people with prediabetes. Leptin is a hormone produced by fat cells that helps regulate appetite and energy use. In people with obesity and prediabetes, leptin levels are often abnormally high, which can contribute to insulin resistance and weight gain. The investigators studied 26 police officers with prediabetes in Indonesia, randomly dividing them into two groups. One group ate sorghum rice instead of white rice for seven consecutive days, while the other group continued eating white rice. Both groups received standard education about healthy eating and exercise. The investigators measured their leptin levels before and after the week-long intervention. Our hypothesis was that replacing white rice with sorghum rice would significantly lower leptin levels.

Conditions

Prediabetic State; Glucose Intolerance; Insulin Resistance; Obesity and Overweight

Keywords

Leptin; obesity; prediabetic; sorghum

Outcome Measures

Primary Outcomes (1)

• Change in Serum Leptin

  Change in serum leptin concentration from baseline to day 7, measured using enzyme-linked immunosorbent assay (ELISA). Delta leptin (Δ leptin) calculated as the difference between post-intervention and pre-intervention leptin levels. Time Frame: Baseline (Day 0) and Day 7 (after 7-day intervention)Unit of Measure: Nanograms per milliliter (ng/mL)

  From Baseline to day 7

Secondary Outcomes (1)

• Serum Leptin Levels at Baseline

  day 0, before intervention

Study Arms (2)

Intervention Arm (Sorghum Group)

EXPERIMENTAL

13 participants Consumed sorghum rice as a dietary substitute for 7 consecutive days Received standard lifestyle education

Dietary Supplement: Sorghum Rice

Control Arm (White Rice Group):

ACTIVE COMPARATOR

13 participants Continued regular white rice consumption Received standard lifestyle education

Dietary Supplement: white rice

Interventions

Sorghum Rice DIETARY_SUPPLEMENT

Participants completely substituted all white rice intake with sorghum rice (Sorghum bicolor L.) for seven consecutive days. The amount consumed at each meal was individually calculated based on participant's daily caloric requirements. Sorghum rice was prepared using standardized cooking procedures supervised by a registered dietitian. Participants consumed sorghum rice with regular meals according to usual eating patterns. Dietary compliance was monitored daily through meal photography reviewed by research staff. Participants maintained all other usual dietary habits including portion sizes of non-grain foods, meal timing, and beverages. Both groups received identical standard lifestyle education on balanced nutrition and physical activity for prediabetes management.

Intervention Arm (Sorghum Group)

white rice DIETARY_SUPPLEMENT

Participants continued habitual white rice (Oryza sativa L.) consumption for seven consecutive days without modification. The amount consumed at each meal was individually calculated based on participant's daily caloric requirements to ensure comparability with the intervention group. Participants consumed white rice with regular meals according to usual eating patterns. Dietary compliance was monitored daily through meal photography reviewed by research staff. Participants maintained all other usual dietary habits including portion sizes of non-grain foods, meal timing, and beverages. Control participants received identical standard lifestyle education on balanced nutrition and physical activity for prediabetes management.

Control Arm (White Rice Group):

Eligibility Criteria

• Age: 18 Years - 58 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18 to 58 years
• Diagnosed with prediabetes which met one of the criteria per PERKENI 2021 as follow:
• Fasting plasma glucose 100-125 mg/dL
• hour postprandial glucose 140-199 mg/dL
• HbA1c 5.7-6.4%
• Willing to comply with dietary monitoring and lifestyle instructions
• Active duty police officers

You may not qualify if:

• Pregnancy
• History of malignancy
• Diagnosed diabetes mellitus
• Acute infection
• Severe hepatic or renal impairment
• Current use of medication such as: glucose-lowering, corticosteroid, or anti-obesity medications

Sponsors & Collaborators

• Dr. Soetomo General Hospital: lead
• Universitas Airlangga: collaborator

Study Sites (1)

Soetomo General Hospital

Surabaya, East Java, 60241, Indonesia

Location

MeSH Terms

Conditions

Prediabetic State; Glucose Intolerance; Insulin Resistance; Obesity; Overweight

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Hyperinsulinism; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sony Wibisono Mudjanarko, dr., Sp.PD, K-EMD, PhD

  Dr. Soetomo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Sony Wibisono M dr., Sp.PD., KEMD, PhD

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 23, 2025
• Study Start: March 1, 2022
• Primary Completion: April 1, 2022
• Study Completion: March 1, 2023
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)