What effect does increasing the amount of dietary carbohydrate have on blood sugar in people with type 2 diabetes?

D-ROC2: Exploring the Dose-Response effect Of Carbohydrate restriction on glycaemia in people with type 2 diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11067343

Enrollment

Registered

2018-11-29

Start date

2018-12-01

Completion date

Unknown

Last updated

2024-01-08

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

Conditions

Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus

Interventions

Current intervention as of 06/02/2020: All diets will be provided to the participants for the duration of the study from Protein Fitness Meals in Kuwait City to ensure compliance to the dietary protoc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Males and post-menopausal females 2. Aged 40-60 years 3. BMI 25-40 kg/m² 4. Reporting a stable weight for 3 months prior to study commencement 5. Able to give informed consent and willing to follow the diets as described in the telephone screening 6. Type 2 diabetes diagnosed within the last 3 years and must be diet-controlled or on metformin which will be withdrawn 2 weeks prior to starting the study

Exclusion criteria

Exclusion criteria: 1. Type 1 or monogenic diabetes. 2. On any medication for type 2 diabetes other than metformin 3. Cancer or any other debilitating disease 4. Kidney disease, liver disease, hematologic abnormalities, congestive heart failure, or untreated thyroid disease

Design outcomes

Primary

Measure	Time frame
Mean 24-hour glucose concentrations over the final 4 days of each dietary period measured using CGM (Medtronic iPro) at each level of carbohydrate intake	—

Secondary

Measure	Time frame
1. Fasting glucose concentrations (averaged from measurements taken 2 hours before breakfast) over the final 4 days of each dietary period measured using CGM (Medtronic iPro) at each level of carbohydrate intake 2. Post-prandial glucose concentrations for 3 hours following a meal (to be identified from the glucose profiles) over the final 4 days of each dietary period measured using CGM (Medtronic iPro) at each level of carbohydrate intake 3. Mean amplitude of glucose excursions (MAGE) over the final 4 days of each dietary period measured using CGM (Medtronic iPro) at each level of carbohydrate intake 4. High blood glucose index over the final 4 days of each dietary period measured using CGM (Medtronic iPro) at each level of carbohydrate intake 5. Body weight, assessed at appointment at the baseline, and day 7 of each dietary period 6. Steps per day, assessed at the baseline, and day 7 of each dietary period measured using Daffodil HPC650 pedometer	—

Measure

Time frame

1. Fasting glucose concentrations (averaged from measurements taken 2 hours before breakfast) over the final 4 days of each dietary period measured using CGM (Medtronic iPro) at each level of carbohydrate intake 2. Post-prandial glucose concentrations for 3 hours following a meal (to be identified from the glucose profiles) over the final 4 days of each dietary period measured using CGM (Medtronic iPro) at each level of carbohydrate intake 3. Mean amplitude of glucose excursions (MAGE) over the final 4 days of each dietary period measured using CGM (Medtronic iPro) at each level of carbohydrate intake 4. High blood glucose index over the final 4 days of each dietary period measured using CGM (Medtronic iPro) at each level of carbohydrate intake 5. Body weight, assessed at appointment at the baseline, and day 7 of each dietary period 6. Steps per day, assessed at the baseline, and day 7 of each dietary period measured using Daffodil HPC650 pedometer

—

Countries

Kuwait

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026