Type 1 DiabetesNCT02154997
The Effect of Different Food Products on Post Prandial Blood Glucose in Pregnant Woman With Diabetes
An observational study of Type 1 Diabetes and Type 2 Diabetes, run by Uri Elchalal at 1 site in Israel.
Trial summary
During pregnancy nutrition demands change and the pregnant woman needs to adjust her food intake and take into consideration the corrected daily recommendations for micro and macro nutrients. Pregnant woman tend to suffer from hyperemesis and this affects their food choice. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes, Gestational Diabetes
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2014to Dec 2017
- Phase
- Observational
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women perticapting in this study will be from the high risk pregnancy clinic of hadassah Ein Kerem.
Who may be able to join
- age 18-45
- women who suffer from type 1 diabetes, type 2 diabetes or gestational diabetes
- Do not suffer from any intestinal disease
- Accept to sign a consent form
Who cannot join
- over age of 45
- under age of 18
- suffer from any intestinal disease
- do not accept to sign a consent form
Trial locations and contacts
1 site in 1 country.
Uriel Elchalal, MD contact
Israel1 site, 1 recruiting
- Recruiting
Hadassah Ein Kerem
Jerusalem, 91120
Uriel Elchalal, MD, uriel@hadassah.org.il
About this study
During pregnancy nutrition demands change and the pregnant woman needs to adjust her food intake and take into consideration the corrected daily recommendations for micro and macro nutrients. Pregnant woman tend to suffer from hyperemesis and this affects their food choice.
Amongst pregnant women with Diabetes the glucose balance is extremely important during pregnancy. Glucose balance is a result of correct nutrition and an exact amount of insulin. This delicate balance requires from the pregnant women an ability to perform correct carbohydrate count.
Hyperglycemia has already been proven to affect the fetus and the neonatal outcomes. Hypoglycemia may also have a negative effect but the main danger is immediate harm to the mother and therefore to the fetus. For those reasons glucose balance is crucial and demands delicate synchronization of nutrition and insulin therapy.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes, Gestational Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 and Type 2 Diabetes | pregnant women which have a known condition of type 1 or type 2 diabetes | |
| Gestational diabetes | pregnant women which have developed Gestational diabetes | |
| Control group | Pregnant women whom do not suffer from any altered glucose metabolism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post prandial blood glucose levels
For every time point blood glucose will be analyzed for blood glucose and for Insulin and C-peptide for the control group
Measured: The outcome will be measured at various time points during a 120 min OGTT: Fasting, 30, 60, 90 and 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startNov 2014
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uri Elchalal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Uri Elchalal, Hadassah Medical Organization
- Investigators
- Ram Weiss, Md PhD, Principal investigator, Hebrew UniverstityKaren J Hershkop, PhD, Principal investigator, Hebrew UniversityLimor Marko, MSc, Principal investigator, Hebrew University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154997
- Sponsor's protocol ID
- HMO-0071-14
- Status last verified
- Feb 2016
- First submitted
- 2 Jun 2014
- Last updated
- 1 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Food Products on Post Prandial Blood Glucose in Pregnant Woman With Diabetes
- ClinicalTrials.gov ID
- NCT02154997
- Acronym / sponsor ID
- HMO-0071-14
- Conditions
- Type 1 Diabetes, Type 2 Diabetes, Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Uri ElchalalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 Jun 2014 (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.
During pregnancy nutrition demands change and the pregnant woman needs to adjust her food intake and take into consideration the corrected daily recommendations for micro and macro nutrients. Pregnant woman tend to suffer from hyperemesis and this affects their food choice.
Amongst pregnant women with Diabetes the glucose balance is extremely important during pregnancy. Glucose balance is a result of correct nutrition and an exact amount of insulin. This delicate balance requires from the pregnant women an ability to perform correct carbohydrate count.
Hyperglycemia has already been proven to affect the fetus and the neonatal outcomes. Hypoglycemia may also have a negative effect but the main danger is immediate harm to the mother and therefore to the fetus. For those reasons glucose balance is crucial and demands delicate synchronization of nutrition and insulin therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type 1 and Type 2 Diabetes | – | –pregnant women which have a known condition of type 1 or type 2 diabetes |
| Gestational diabetes | – | –pregnant women which have developed Gestational diabetes |
| Control group | – | –Pregnant women whom do not suffer from any altered glucose metabolism |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women perticapting in this study will be from the high risk pregnancy clinic of hadassah Ein Kerem.
Key inclusion criteria (4 listed)
- age 18-45
- women who suffer from type 1 diabetes, type 2 diabetes or gestational diabetes
- Do not suffer from any intestinal disease
- Accept to sign a consent form
Key exclusion criteria (4 listed)
- over age of 45
- under age of 18
- suffer from any intestinal disease
- do not accept to sign a consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post prandial blood glucose levels
Time frame: The outcome will be measured at various time points during a 120 min OGTT: Fasting, 30, 60, 90 and 120 min
For every time point blood glucose will be analyzed for blood glucose and for Insulin and C-peptide for the control group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2016.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Uriel Elchalal, MD contact
Ram Weiss, Md PhD principal investigator
Hebrew Universtity
Karen J Hershkop, PhD principal investigator
Hebrew University
Limor Marko, MSc principal investigator
Hebrew University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Type 2 Diabetes, run by Uri Elchalal at 1 site in Israel.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Mar 2016. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Uriel Elchalal, MD (uriel@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post prandial blood glucose levels (time frame: The outcome will be measured at various time points during a 120 min OGTT: Fasting, 30, 60, 90 and 120 min). 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 1 Mar 2016.