Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-25 @ 4:56 AM
NCT ID:
NCT01585818
Eligibility Criteria:
Inclusion Criteria:
1. Be willing and able to comply with study procedures and give written informed consent
2. Have established diagnosis of type 2 diabetes\* of more than 1 year on diet treatment or oral anti-diabetic therapy
3. Male or female, aged 45 to 64 years inclusive
4. HbA1c of 7.0 - 10.0% (inclusive) within the last 3 months or at screening
5. Stable glycaemic control
6. Patients with concurrent illnesses if medically stable for 6 months prior to screening visit, based on the clinical judgement of the investigator
7. Be on stable therapy (no significant change to therapy in last 3 months)
8. No hospitalization or surgery in the past 6 months
9. No use of corticosteroids in the last 6 months
10. Not pregnant
11. Urea \<30 mmol/L and estimated GFR \>= 60ml/min
12. Be willing to prepare and adhere to the meal plans and consume at least two meals at home per day.
13. Be willing and able to undertake blood glucose monitoring, continuous glucose monitoring.
* Subjects with Type 2 DM should have been diagnosed at least 1 years prior to the screening visit and should not have T1DM, MODY or secondary diabetes e.g. diabetes secondary to chronic pancreatitis
Exclusion Criteria:
1. Significant medical conditions which in the Investigator's opinion would confound interpretation of the results, including but not limited to: current symptomatic cardiovascular disease, macroalbuminuria (dipstick positive proteinuria on more than 1 consecutive occasion) or renal impairment (serum creatinine above 120 umol/l), cancer, overt liver disease other than Non Alcoholic Steatohepatitis (liver enzyme levels less than 3 times upper limit of normal) or gastroparesis.
2. Recent changes in weight of \>5% over the past 6 months
3. Significant changes in diet over the past 6 months
4. Any use of weight reducing drugs, or on medications such as alpha-glucosidase inhibitors or insulin currently or in the past 6 months
5. Any surgery (and bariatric surgery) in the past 6 months
6. Any use of investigational drugs in the past 6 months
7. Any serious illness requiring hospitalization in the past 6 months
8. Any use of corticosteroids in the past 6 months
9. Ongoing infection, or condition that interfered with nutrient digestion, absorption, metabolism or excretion (including gastroparesis)
10. Allergy or intolerant to the ingredients or any of the food items in the intervention diet or to paracetamol/ acetaminophen
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
64 Years
Study:
NCT01585818
Study Brief:
Protocol Section:
NCT01585818