Diabetic NephropathyNCT02384902
Effect of Low GI/ Glycemic Load (GL) Diet in Diabetic Nephropathy Patients
A study testing low GI and conventional diet in people with Diabetic Nephropathy and Medication Compliance, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
low GI and low GL diet have more beneficial effect for diabetic nephropath patients compared with conventional diet. low GL may have more favorable effect than low GI diet. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diabetic Nephropathy, Medication Compliance
- What is being tested?
- low GI and conventional diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIran
- Study dates
- May 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diabetic nephropathy, medication stable
Who cannot join
- poor adherence of dietary recommendations, any changes in kind or dosage of medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dietary Glycemic Index/Load on Kidney-related Biomarkers and Inflammation in Diabetic Nephropathy Patients
low GI and low GL diet have more beneficial effect for diabetic nephropath patients compared with conventional diet.
low GL may have more favorable effect than low GI diet.
Read the detailed description
According to body weight status of participants, the investigators considered a slight calorie restriction ranged from 200 to 300 Kcal/d. Planed meals and exchange list prescribed for all volunteers. Dietary records forms were given to all subjects and they were educated how to record their dietary intakes. The investigators asked subjects not to change their physical activity level during the study and monitored them for their physical activity level by 3 days physical activity records monthly.
- Conditions
- Diabetic Nephropathy, Medication Compliance
- Being tested
- low GI, conventional diet
- Keywords
- glycemic index, diabetic nephropathy, low glycemic load, inflammation
- Medical subject headings
- Diabetic Nephropathies, Medication Adherence, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low GIOther
All diets were designed with similar macronutrients content (30% fat, 0.8 g/kg/d protein and remained calorie requirement by carbohydrate). Additionally, we controlled phosphorus, sodium and potassium content of diets for three intervention groups. All dietary menus had less than 1500 mg phosphor and less than 2400 mg sodium and 2000 mg potassium.
low GIOther
All diets were designed with similar macronutrients content (30% fat, 0.8 g/kg/d protein and remained calorie requirement by carbohydrate). Additionally, we controlled phosphorus, sodium and potassium content of diets for three intervention groups. All dietary menus had less than 1500 mg phosphor and less than 2400 mg sodium and 2000 mg potassium.
conventional dietOther
All diets were designed with similar macronutrients content (30% fat, 0.8 g/kg/d protein and remained calorie requirement by carbohydrate). Additionally, we controlled phosphorus, sodium and potassium content of diets for three intervention groups. All dietary menus had less than 1500 mg phosphor and less than 2400 mg sodium and 2000 mg potassium.
| Study group | Role | What they receive |
|---|---|---|
| low GI | Experimental | low GI: participants were asked to consume low GI foods (GI<55) in abundant, medium GI in moderate and high GI (GI>70) rarely. Receives: Other: low GI |
| low GL | Experimental | low GL: participants were asked to consume low GI foods and the amount of carbohydrate was controlled. Receives: Other: low GI |
| conventional diet | Experimental | conventional diet: all carbohydrate were treated as the same. Receives: Other: conventional diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum creatinine (and blood urea nitrogen (BUN) (mg/dL) were measured by colorimetric method and enzymatic colorimetric method using commercial assay kit.
Measured: baseline, wk 12
Secondary outcomes (1)
Serum levels of high sensitive C- reactive protein (hs-CRP) (mg/L) were quantified by using an ultrasensitive latex-enhanced immunoturbidimetric assay (Randox Laboratory Ltd., Belfast, United Kingdom).
Measured: baseline, wk 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startMay 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Azadbakht, Isfahan University of Medical Sciences
- Investigators
- leila azadbakht, phd, Principal investigator, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384902
- Sponsor's protocol ID
- low GI nephropathy
- Status last verified
- Mar 2015
- First submitted
- 6 Sep 2014
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Glycemic Index/Load on Kidney-related Biomarkers and Inflammation in Diabetic Nephropathy Patients
- ClinicalTrials.gov ID
- NCT02384902
- Acronym / sponsor ID
- low GI nephropathy
- Conditions
- Diabetic Nephropathy, Medication Compliance
- Keywords
- glycemic index, diabetic nephropathy, low glycemic load, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 10 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
low GI and low GL diet have more beneficial effect for diabetic nephropath patients compared with conventional diet.
low GL may have more favorable effect than low GI diet.
Detailed description
According to body weight status of participants, the investigators considered a slight calorie restriction ranged from 200 to 300 Kcal/d. Planed meals and exchange list prescribed for all volunteers. Dietary records forms were given to all subjects and they were educated how to record their dietary intakes. The investigators asked subjects not to change their physical activity level during the study and monitored them for their physical activity level by 3 days physical activity records monthly.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low GI | Experimental | Other: low GIlow GI: participants were asked to consume low GI foods (GI<55) in abundant, medium GI in moderate and high GI (GI>70) rarely. |
| low GL | Experimental | Other: low GIlow GL: participants were asked to consume low GI foods and the amount of carbohydrate was controlled. |
| conventional diet | Experimental | Other: conventional dietconventional diet: all carbohydrate were treated as the same. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diabetic nephropathy, medication stable
Key exclusion criteria (1 listed)
- poor adherence of dietary recommendations, any changes in kind or dosage of medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low GIAll diets were designed with similar macronutrients content (30% fat, 0.8 g/kg/d protein and remained calorie requirement by carbohydrate). Additionally, we controlled phosphorus, sodium and potassium content of diets for three intervention groups. All dietary menus had less than 1500 mg phosphor and less than 2400 mg sodium and 2000 mg potassium. | Other | low GI |
| low GIAll diets were designed with similar macronutrients content (30% fat, 0.8 g/kg/d protein and remained calorie requirement by carbohydrate). Additionally, we controlled phosphorus, sodium and potassium content of diets for three intervention groups. All dietary menus had less than 1500 mg phosphor and less than 2400 mg sodium and 2000 mg potassium. | Other | low GL |
| conventional dietAll diets were designed with similar macronutrients content (30% fat, 0.8 g/kg/d protein and remained calorie requirement by carbohydrate). Additionally, we controlled phosphorus, sodium and potassium content of diets for three intervention groups. All dietary menus had less than 1500 mg phosphor and less than 2400 mg sodium and 2000 mg potassium. | Other | conventional diet |
Primary outcome
Serum creatinine (and blood urea nitrogen (BUN) (mg/dL) were measured by colorimetric method and enzymatic colorimetric method using commercial assay kit.
Time frame: baseline, wk 12
1 secondary outcome
Serum levels of high sensitive C- reactive protein (hs-CRP) (mg/L) were quantified by using an ultrasensitive latex-enhanced immunoturbidimetric assay (Randox Laboratory Ltd., Belfast, United Kingdom).
Time frame: baseline, wk 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
leila azadbakht, phd principal investigator
Isfahan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low GI and conventional diet in people with Diabetic Nephropathy and Medication Compliance, run by Isfahan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum creatinine (and blood urea nitrogen (BUN) (mg/dL) were measured by colorimetric method and enzymatic colorimetric method using commercial assay kit. (time frame: baseline, wk 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.