Status:
UNKNOWN
Effect of Milk Consumption on Glycemia and Gut Microbiome in T2D
Lead Sponsor:
Tel Aviv University
Conditions:
Type2Diabetes
Eligibility:
All Genders
30-75 years
Phase:
NA
Brief Summary
The overall glycemic excursions display circadian variations which are controlled by the circadian clock genes (CCG) and are strongly influenced by meal timing. Indeed, in T2D, a diet aligned with th...
Detailed Description
Background: Reduction of the overall glycemic excursion is the main target in the treatment of T2D to reduce HbA1c and cardiovascular risk. The overall glycemic excursions display circadian variations...
Eligibility Criteria
Inclusion
- Patients diagnosed with T2D \< 20 years
- HbA1c ≥ 6.5 %.
- BMI - 28-45 kg/m2
- Men and women 30 -75 years of age inclusive
- Normal liver, kidney, and thyroid functions, and eGFR \> 45 mL/min/1.73 m2.
- Type 2 diabetes controlled with diet, lifestyle alone, or with antidiabetics other than insulin (i.e. biguanides, sulfonylureas, glinides, SGLT2 inhibitors, DPP4 inhibitors, GLP-1 analogs), with stable doses for at least 3 months before entering the study.
- Stable weight (less than 5% change in body weight in last 3 months before the study - determined by self-reporting or documentation in clinical records).
- Concomitant medication i.e. antihypertensive, anti-lipidemic, anti-thrombotic drugs will be allowed also on a stable dose for at least 3 months before the beginning of the trial.
- Patients that usually wake up between 06:00 and 08:00 and go to sleep between 22:00 and 24:00.
- Should not have shift work within 6 months of the study and should not have crossed time zones within 2 weeks of the study.
- No change in medication or nutrition supplements or physical activity will be made during the study.
Exclusion
- Type 1 diabetes or secondary forms of diabetes.
- Patients with latent autoimmune diabetes in adults (LADA).
- Treatment with insulin.
- Serum creatinine level \>2mg/dl. Renal dysfunction: eGFR \< 45 mL/min/1.73 m2).
- Hepatic dysfunction: liver disease or transaminase levels \> 2.5-fold above normal.
- Major illness with life expectancy \< 5 years.
- Malignant neoplasm requiring chemotherapy, surgery, radiation, or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer).
- Those taking psychotropic, anorectic medication, steroid treatment, or illicit drug abuse or alcoholism within one year prior to study onset. Pregnancy or lactation.
- Known hypersensitivity to milk components or lactose intolerance.
- Night or rotating shift workers or those who crossed more than 2 time zones during the 2- week period prior to study onset.
- Not able to give informed consent
Key Trial Info
Start Date :
April 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 28 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05294861
Start Date
April 28 2022
End Date
December 28 2022
Last Update
March 24 2022
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